gixxer11
13 years ago
Right on que - gotta love America
Robbins Umeda LLP Announces an Investigation of Ardea Biosciences, Inc.
Shareholder rights firm Robbins Umeda LLP has commenced an investigation into possible breaches of fiduciary duty and other violations of the law by members of the board of directors of Ardea Biosciences, Inc. (NASDAQ: RDEA) in connection with their efforts to sell the company to AstraZeneca. Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Gregory E. Del Gaizo at (800) 350-6003, info@robbinsumeda.com, or via the shareholder information form on the firm's website.
On April 23, 2012, Ardea announced that it had entered into a definitive merger agreement to be acquired by AstraZeneca. According to the terms of the deal, AstraZeneca will acquire all outstanding shares of the company through an all-cash transaction. Pursuant to the agreement, Ardea shareholders will receive $32.00 for each share of the company they own. The transaction is expected to close during the second or third quarter of 2012.
Robbins Umeda LLP's investigation focuses on whether Ardea's board is undertaking a fair process to obtain maximum value and adequately compensate shareholders in light of the prospects for lesinurad, the company's drug in Phase III development as a potential treatment for the chronic management of hyperuricaemia in patients with gout. On March 9, 2012, the company announced that the $157.6 million it raised in a recent equity offering should be sufficient to fund Ardea's operations beyond the preliminary endpoint dates for all four Phase III studies of lesinurad currently underway. Additionally, at least three leading market analysts released target prices for Ardea above the price offered by Astra Zeneca, including one that values the company's stock at $41.00 per share.
Robbins Umeda LLP attorneys highlight that Ardea shareholders have the option to file a class action lawsuit against the company to secure the best possible price for the company's shareholders and the disclosure of material information to shareholders so they can vote on the transaction in an informed manner.
Robbins Umeda LLP is a nationally recognized leader in securities litigation and shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested. For more information, please go to http://www.robbinsumeda.com.
surf1944
13 years ago
Ardea Biosciences to Present Data From Gout Program at the 2011 ACR/ARHP Annual Scientific Meeting
Press Release Source: Ardea Biosciences, Inc. On Wednesday October 19, 2011, 8:30 am EDT
SAN DIEGO, CA--(Marketwire -10/19/11)- Ardea Biosciences, Inc. (NASDAQ: RDEA - News) today announced that additional data from the ongoing extension portion of a Phase 2b study (Study 203) of lesinurad, Ardea's lead product candidate for the chronic treatment of gout, in combination with allopurinol in patients who did not achieve target serum urate (sUA) levels on allopurinol therapy alone, will be presented at the 2011 ACR/ARHP Annual Scientific Meeting on Monday, November 7, 2011 in Chicago, IL. The Company will also present combined data from multiple Phase 2b studies evaluating the pharmacokinetics, efficacy and safety profile of lesinurad in patients with mild to moderate renal impairment as well as an oral presentation on biological activity and binding of high affinity URAT1 transporter inhibitors.
Presentation details are as follows:
Poster Title: Efficacy and Safety of Lesinurad (RDEA594), A Novel
Uricosuric Agent, Given in Combination with Allopurinol
in Allopurinol-Refractory Gout Patients: Preliminary
Results from the Randomized, Blinded, Placebo-
Controlled, Phase 2b Extension Study
Session Title: Metabolic and Crystal Arthropathies Poster II: Anti-Gout
Therapy and Outcome
Poster Number: 1021
Date/Time: Monday, November 7, 2011 from 9:00 AM - 6:00 PM CST
Location: McCormick Place Convention Center: Poster Hall
Poster Title: Pharmacokinetics, Efficacy and Safety of Lesinurad, A
Novel URAT1 Inhibitor, in Individuals with Mild to
Moderate Renal Impairment
Session Title: Metabolic and Crystal Arthropathies Poster II: Anti-Gout
Therapy and Outcome
Poster Number: 1030
Date/Time: Monday, November 7, 2011 from 9:00 AM - 6:00 PM CST
Location: McCormick Place Convention Center: Poster Hall
Presentation Title: Identification of Specific Amino Acids in the Uric Acid
Transporter URAT1 Required for Uricosuric-Mediated
Inhibition
Session Title: Plenary Session II - Oral Presentation
Abstract Number: 1592
Date/Time: Monday, November 7, 2011 from 12:15 PM - 12:30 PM CST
Location: McCormick Place Convention Center: W 375 C Presentation
About Hyperuricemia and Gout
Gout is a painful, debilitating and progressive disease caused by abnormally elevated levels of uric acid in the blood stream. This leads to the deposition of painful, needle-like uric acid crystals in and around the connective tissue of the joints and in the kidneys, resulting in inflammation, the formation of disfiguring nodules, intermittent attacks of severe pain and kidney damage. In addition, evidence suggests that the chronic elevation of uric acid associated with gout, known as hyperuricemia, may also have systemic consequences, including an increased risk for kidney dysfunction and cardiovascular disease.
In 2008, approximately 8.3 million patients in the U.S., 9 million patients in the European Union and 2.9 million patients in Japan had been diagnosed with gout. Gout is the most common form of inflammatory arthritis in men over the age of 40 and represents a significant unmet medical need with limited treatment options.
About Lesinurad
Lesinurad is our most advanced product candidate for the chronic treatment of gout. Lesinurad is an oral, once-daily inhibitor of URAT1, a transporter in the kidney that regulates uric acid excretion from the body. Approximately 90 percent of gout patients are considered to be under-excretors of uric acid, and recent studies have shown that defects in renal transporters have been genetically linked to gout. Consequently, increasing renal excretion of uric acid by moderating URAT1 transporter activity may provide the most physiologically appropriate means of reducing sUA levels. In addition, because increasing the excretion of uric acid is additive to the effects of drugs known as xanthine oxidase inhibitors that decrease the production of uric acid, including allopurinol and febuxostat, lesinurad in combination with such drugs has the potential to treat the significant portion of the gout population that is not adequately treated with existing therapies.
Lesinurad has been evaluated as a single agent and in combination with the approved xanthine oxidase inhibitors, allopurinol and febuxostat. Over 500 people have received lesinurad in Phase 1 and 2 clinical trials.
surf1944
14 years ago
Ardea Biosciences, Inc. (RDEA) develops drugs for "the treatment of gout, human immunodeficiency virus (HIV), and cancer. The products include: RDEA594, a Phase IIb clinical trial product for the gout; RDEA684, a preclinical trial product for gout with hyperuricemia; RDEA806, a non-nucleoside reverse transcriptase inhibitor, which completed Phase II clinical trial for the treatment of patients with HIV; and RDEA427, which is in first-in-human micro-dose pharmacokinetic study for the treatment of HIV infection. RDEA is evaluating RDEA119, an inhibitor of Mitogen-activated ERK kinase (MEK), which is in Phase I/II study in combination with sorafenib and as a single agent in a Phase I study, both in advanced cancer patients. The company has a license agreement with Bayer to develop and commercialize MEK inhibitors for various indications." (Yahoo Finance) RDEA has short interest of 18.10% as a percentage of the float. It could get short squeezed, but this could also push RDEA downward in the near term, if there is no positive news. The recent PJ downgrade of RDEA to neutral is not a positive sign. The company has a good cash position with $80.61M, while it carries only $3.56M in debt. Plus insiders have bought 495,549 shares of RDEA in the last 6 months. This is approx. $12.88M at a price of $26 (the current price is $28.35). This indicates a strong belief in the company's prospects longer term by people who should know the most. This company is worth a good look. The average analysts' recommendation is 1.3.
All of these stocks are worth watching closely. The first two would seem to have better chances of near term upside. They both have high Betas though, which means they could go down quickly in an overall market downturn. Watch carefully for this. RDEA's Beta is only 1.1. It should move down less quickly in a market downturn, but it will move up more slowly too. I note the market looked suspiciously weak today (Monday).
http://seekingalpha.com/article/267236-3-biotech-stocks-on-the-edge-of-success?source=yahoo
surf1944
15 years ago
Ardea Biosciences to Present at Two Upcoming Investor Conferences
Press Release Source: Ardea Biosciences, Inc. On Thursday May 6, 2010, 9:00 am
SAN DIEGO, May 6 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq:RDEA - News) announced today that Barry D. Quart, PharmD, president and chief executive officer, will present at the following upcoming investor conferences:
•9th Annual JMP Securities Research Conference in San Francisco, California. Presentation: 9:00 a.m. PDT on Monday, May 10, 2010.
•Bank of America Merrill Lynch Healthcare Conference in New York, New York. Presentation: 8:40 a.m. EDT on Thursday, May 13, 2010.
A live audio webcast of each presentation will be available under the investor relations section of Ardea's website at http://www.ardeabio.com/. A replay will be available for 30 days following each event. Please connect to Ardea's website several minutes prior to the start of the webcast to ensure adequate time for any software download that may be necessary.
surf1944
15 years ago
UPDATE 1-Ardea says gout drug meets mid-stage study goal
Wed Mar 31, 2010 5:14pm EDTStocks
* RDEA594 meets primary study goal
* Says the drug was well tolerated
* Shares up 10 pct after-market
March 31 (Reuters) - Ardea Biosciences Inc (RDEA.O) said its experimental drug for the treatment of hyperuricemia, or excessive uric acid in the blood, in patients with gout met a study goal, sending its shares up 10 percent. In a mid-stage trial, the drug, RDEA594, met the primary endpoint of showing a significant increase in the proportion of patients with reduced serum urate levels after four weeks of treatment, compared to the dummy pill, the company said in a statement.
In the study, 123 gout patients with hyperuricemia received the drug in three dosages -- 200 mg, 400 mg, and 600 mg or the matching dummy pill.
Reductions in serum urate and response rates increased in a dose-related manner and were highly clinically and statistically significant at both the 400 mg and 600 mg dose levels.
In the study, the drug was well tolerated and there were no serious adverse events, the company said.
Shares of the company rose 10 percent to $20.00 in after market trade. They closed at $18.26 Wednesday on Nasdaq. (Reporting by Shailesh Kuber in Bangalore; Editing by Saumyadeb Chakrabarty)
surf1944
15 years ago
Ardea Biosciences Reports Positive Results for RDEA594, its Lead Product Candidate for Gout, in Combination with Allopurinol or Febuxostat
- 100% of patients reached target serum urate levels with the combination of RDEA594 and allopurinol
- RDEA594 combined with febuxostat reduced serum urate levels in healthy volunteers by approximately 70%
Press Release Source: Ardea Biosciences, Inc. On Thursday January 7, 2010, 8:30 am
SAN DIEGO, Jan. 7 /PRNewswire-FirstCall/ --Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced additional positive results from a recently completed Phase 2a study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, as well as additional positive results from the second panel of a Phase 1 drug-drug interaction and pharmacodynamic study of RDEA594 in combination with febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen and Menarini).
"The impressive reduction in serum urate observed when RDEA594 and febuxostat or allopurinol are co-administered indicate that these oral agents with complementary mechanisms may be able to produce reductions in serum urate previously achieved only with intravenous therapy," said Mark Genovese, MD, professor of medicine and Co-Chief of the Division of Immunology and Rheumatology at Stanford University Medical Center and a member of Ardea's scientific advisory board. "I look forward to studying these combinations in patients with advanced disease."
The combination of RDEA594 and allopurinol reduced serum urate (sUA) levels an additional 24 percent compared to allopurinol alone in the second cohort of a Phase 2a proof-of-concept study evaluating the sUA lowering effect, safety and tolerability of combining RDEA594 and allopurinol in gout patients with hyperuricemia (sUA levels of at least 9 mg/dL). Patients in this cohort received 300 mg of allopurinol once daily (QD) for one week, followed by the addition of 200 mg of RDEA594 or placebo QD for the second week, and 400 mg of RDEA594 or placebo QD in addition to allopurinol for the third and final week. After one week on allopurinol alone, sUA levels were reduced by 39 percent to a mean of 6.3 mg/dL, with 50 percent of patients responding. Response was defined as achieving a target sUA level of less than 6.0 mg/dL. Adding 200 mg of RDEA594 QD to allopurinol for an additional week produced a 48 percent reduction in sUA from baseline with all patients responding. Increasing the dose to 400 mg of RDEA594 QD for an additional week resulted in a 54 percent reduction of sUA from a baseline of 10.2 mg/dL to a mean of 4.6 mg/dL, which represents a 24 percent reduction in sUA levels from levels achieved on allopurinol alone. All patients responded and 80 percent of patients achieved sUA levels below 5 mg/dL. The combination of RDEA594 and allopurinol was well tolerated and no significant laboratory abnormalities were reported. In the previously reported first cohort of this study, RDEA594 produced significant reductions in sUA levels, was effective in patients with mild to moderate renal impairment, and was well tolerated as a single agent in gout patients with hyperuricemia.
In the second panel of a drug-drug interaction and pharmacodynamic study of RDEA594 with febuxostat in healthy volunteers, 400 mg of RDEA594 QD and 40 mg of febuxostat QD reduced mean sUA levels by 49 and 45 percent, respectively, when used alone. The combination of RDEA594 with febuxostat resulted in approximately a 70 percent mean reduction in sUA levels compared to baseline, with intraday reductions of over 80 percent, reaching mean sUA levels of 1.2 mg/dL. These results compare favorably to the mean serum urate reductions previously reported with the first dosing group of approximately 60 percent from baseline when 200 mg of RDEA594 QD was administered in combination with 40 mg of febuxostat QD for 7 days. The combination of RDEA594 and febuxostat was well tolerated, with Grade 2 elevations of liver enzymes associated with febuxostat treatment as the only significant laboratory abnormalities.
"These results demonstrate the potential to use RDEA594 in combination with the most widely prescribed class of gout medications to achieve greater levels of serum urate reduction than can be achieved using a xanthine oxidase inhibitor alone," said Barry D. Quart, PharmD, Ardea's president and chief executive officer. "Given its complementary mechanism of action, we believe that RDEA594 is well positioned to meet a significant unmet medical need for patients who do not adequately respond to, or who are intolerant to, currently available gout medications."
About Hyperuricemia and Gout
Gout is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. In large clinical trials, approximately 60 percent of patients did not respond adequately to treatment with allopurinol alone. Allopurinol is the most widely-prescribed xanthine oxidase inhibitor. It acts by reducing the production of uric acid in the body. Approximately 10 percent of gout patients are believed to produce too much uric acid. The other 90 percent are considered to have a defect in their ability to excrete sufficient amounts of uric acid and are classified as under-excretors of uric acid.
surf1944
15 years ago
Ardea Biosciences Reports Recent Accomplishments and Announces Third Quarter and Year-to-Date 2009 Financial Results
Press Release
Source: Ardea Biosciences, Inc.
On 8:00 am EST, Friday November 6, 2009
Companies:Ardea Biosciences, Inc.
SAN DIEGO, Nov. 6 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV), today reported recent accomplishments and financial results for the third quarter and nine months ended September 30, 2009.
"Since our last quarterly update, we have confirmed the activity of RDEA594 in gout patients, and we have initiated the four planned studies in our broad-based Phase 2 development program," commented Barry D. Quart, PharmD, Ardea's president and chief executive officer. "The Phase 2a results demonstrate the ability of RDEA594 to normalize renal excretion of uric acid in patients that have gout due to their inability to excrete sufficient amounts of uric acid. These under-excretors of uric acid make up approximately 90% of the patients with hyperuricemia and gout, and are the primary target population for RDEA594," added Dr. Quart.
Recent Accomplishments
On October 19, 2009, we presented at the 2009 American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania, additional data from the first cohort of an ongoing Phase 2a proof-of-concept study of RDEA594, our lead product candidate in development for the treatment of hyperuricemia and gout. Important highlights from this study were:
All patients receiving RDEA594 experienced a dose-related reduction in serum uric acid levels and a majority achieved a reduction in serum urate to levels less than 6 mg/dL.
60% (6/10) of patients in this group who excrete less than normal amounts of uric acid in their urine responded to therapy by achieving a reduction in serum urate to levels less than 6 mg/dL after two weeks of treatment.
RDEA594 also produced significant reductions in serum urate in patients with mild to moderate renal impairment, with 83% (5/6) of these patients responding after two weeks of treatment. Gout patients with mild to moderate renal impairment represent a substantial portion of the gout patient population and are often not effectively treated with allopurinol.
RDEA594 was also well tolerated in this study, with no serious adverse events and no premature discontinuations due to adverse events in patients receiving RDEA594.
Ardea also presented at the ACR/ARHP meeting data from preclinical drug-drug interaction studies demonstrating RDEA594's potential to be used in combination with allopurinol and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen) and an update from a 3- and 6-month assessment of chronic toxicity in rats and monkeys, respectively, showing no organ toxicity at doses up to 300 mg/kg/day.
Clinical Development Efforts and Important Upcoming Clinical Development Milestones
All studies in our RDEA594 Phase 2 clinical development program have been initiated. These studies include a Phase 2b single-agent dose-response study evaluating the safety and urate-lowering effects of 200, 400 and 600 mg of RDEA594 in 140 gout patients (RDEA594-202), a Phase 2b combination study evaluating RDEA594 as an add-on to allopurinol in approximately 100 patients who do not respond adequately to allopurinol alone (RDEA594-203), a drug-drug interaction study with febuxostat in healthy volunteers (RDEA594-105), and a study in gout patients with renal impairment (RDEA594-204).
We expect to provide results from the second cohort of our ongoing Phase 2a proof-of-concept study evaluating RDEA594 in combination with allopurinol and Study RDEA594-105, along with an update on progress in RDEA594-204, in December 2009. We expect RDEA594-202 to complete enrollment in 2009, with results anticipated in the first quarter of 2010. We also expect to report results from RDEA594-203 in the first quarter of 2010.
In coordination with our commercial partner, Bayer HealthCare AG (Bayer), we continue to progress our ongoing Phase 1/2 study of RDEA119 in combination with sorafenib (Nexavar®, Bayer and Onyx Pharmaceuticals) and our ongoing Phase 1 monotherapy study of RDEA119 in advanced cancer patients.
Third Quarter and Year-to-Date 2009 Financial Results
As of September 30, 2009, we had $59.6 million in cash, cash equivalents, and short-term investments, and $1.4 million in receivables, compared to $57.7 million in cash, cash equivalents, and short-term investments, and $0.4 million in receivables as of December 31, 2008. The increase in cash, cash equivalents and short-term investments and receivables for the first nine months of 2009 was primarily due to the receipt of a $35.0 million non-refundable, upfront license fee and the expected reimbursement of third-party development costs associated with our MEK inhibitor program under our license agreement with Bayer, offset by the use of cash to fund our clinical-stage programs, personnel costs and for other general corporate purposes.
We anticipate that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operating activities through the first quarter of 2011. This current financial projection includes forecasted expenses associated with the RDEA594 Phase 2 and Phase 3 programs anticipated for that period, combined with expense reductions from our recent restructuring. This projection does not include any milestone payments under our license agreement with Bayer, proceeds from future partnering activities or financings, or potential payments under our asset purchase agreement with Valeant.
Revenues totaled $9.2 million and $14.7 million for the three and nine months ended September 30, 2009, respectively. There were no revenues for the three months ended September 30, 2008 and revenues totaled $0.3 million for the nine-month period ended September 30, 2008. The revenues earned during the first nine months of 2009 resulted from the recognition of a portion of the upfront, non-refundable license fee and reimbursement of third-party development costs under our license agreement with Bayer. The $35.0 million upfront license fee is being recognized on a straight-line basis over a period of approximately 13 months, which is the anticipated timeframe in which the Company expects to complete all of its obligations under the license agreement. The revenue earned in fiscal 2008 resulted from the research services we provided under our master services agreement with Valeant, which has since terminated by its terms.
The net loss applicable to common stockholders for the three and nine months ended September 30, 2009 was $2.5 million and $24.5 million, or $0.13 per share and $1.36 per share, respectively, compared to a net loss applicable to common stockholders for the same periods in 2008 of $14.2 million and $42.4 million, or $0.95 per share and $2.98 per share, respectively. The net loss applicable to common stockholders for the three and nine months ended September 30, 2009 included non-cash charges of $1.3 million and $4.3 million, or $0.07 per share and $0.24 per share, respectively, for stock-based compensation expense. For the same period in 2008, we reported non-cash charges of $1.3 million and $3.7 million, or $0.09 per share and $0.26 per share, respectively, for stock-based compensation expense.
The decrease in net loss applicable to common stockholders between these periods was primarily a result of the increase in revenues noted above for the same period, and a decrease in operating expenses, mainly due to reduced discovery research and clinical development expenditures as we continue to focus our resources on our gout-related programs, RDEA594 and RDEA684. In addition, during the third quarter of 2009, we realized savings from our restructuring plan of approximately $1.1 million. These decreases were partially offset by severance-related restructuring charges of approximately $0.1 million and $0.8 million for the three and nine months ended September 30, 2009, respectively, an increase in interest expense in connection with our growth capital loan and capital lease obligations entered into in the second half of 2008 and a decline in interest income due to lower average interest rates as compared to 2008.
surf1944
15 years ago
Ardea Biosciences Announces Additional Positive Results from a Phase 2a Study of RDEA594 at the 2009 ACR/ARHP Annual Scientific Meeting
RDEA594 Significantly Reduced Serum Urate Levels in Gout Patients and Was Well Tolerated
Conference Call and Webcast Scheduled for 11:30 A.M. Eastern Time Today
Press Release
Source: Ardea Biosciences, Inc.
On 7:30 am EDT, Monday October 19, 2009
Companies:Ardea Biosciences, Inc.
SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced additional positive results from the completed first cohort of an ongoing Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout. These results, as well as data from a preclinical drug-drug interaction study demonstrating RDEA594’s potential to be used in combination with allopurinol and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen), are being presented today at the 2009 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania.
In the first cohort of this small placebo- and active-controlled study of 21 gout patients with hyperuricemia (serum urate ≥ 8 mg/dL), 11 patients were randomized to blinded RDEA594 200 mg once-daily (qd) for one week followed by RDEA594 400 mg qd for one week, 5 patients were randomized to blinded placebo for two weeks and 5 patients were randomized to open-label allopurinol 300 mg qd for two weeks. All patients receiving RDEA594 experienced a dose-related reduction in uric acid levels in their blood. Patients who excrete less than normal amounts of uric acid make up approximately 90% of the gout patient population and are the primary target for treatment with RDEA594. In this study, the response rate (response defined as serum urate to < 6 mg/dL) to RDEA594 in these patients was 60% (6/10) after two weeks of treatment. A majority of patients randomized to RDEA594 also had mild to moderate renal impairment (Creatinine Clearance by Cockcroft-Gault method = 50-89 ml/min) at baseline and 86% of those patients responded to RDEA594 at two weeks.
RDEA594 increased urinary excretion of uric acid in the under-excretor patients in this study to pre-treatment levels seen in normal healthy volunteers in prior studies. Avoiding excessive clearance of uric acid should reduce the risk of renal toxicity. RDEA594 was also well tolerated in this study, with no serious adverse events and no premature discontinuations due to adverse events in patients receiving RDEA594.
In the ongoing second cohort of this trial, 6 gout patients with hyperuricemia (serum urate ≥ 9 mg/dL) will receive allopurinol 300 mg qd for one week followed by the addition of RDEA594 or placebo for two more weeks.
Preclinical models did not show any drug-drug interactions between RDEA594 and either allopurinol or febuxostat. Ongoing studies in humans will provide additional evidence to support the potential use of these combinations. An update on animal safety studies was also presented with recent results from a 3-month and 6-month assessment of chronic toxicity in rats and monkeys, respectively, showing no organ toxicity with RDEA594. In particular, no renal toxicity was noted in clinical chemistry, gross pathology or histopathology at doses up to 300 mg/kg/day.
“RDEA594 continues to move through clinical development with an impressive efficacy and safety profile. The significant activity observed in patients with mild to moderate renal impairment, a substantial group of gout patients that are not effectively treated with allopurinol, is extremely encouraging,” commented Barry D. Quart, PharmD, Ardea’s president and chief executive officer. “Results presented today provide an important first look at what we expect to see in the larger single-agent Phase 2b dose-response trial now underway, as well as validation of the doses selected for all studies in the Phase 2 program.”
The ACR/ARHP posters are available on the Company’s website (www.ardeabio.com) under the titles, “RDEA594, a Novel Uricosuric Agent, Significantly Reduced Serum Urate Levels and Was Well Tolerated in a Phase 2a Pilot Study in Hyperuricemic Gout Patients” and “Evaluation of Drug-Drug Interaction Potential Between RDEA594, Allopurinol and Febuxostat in Preclinical Species.”
Ardea will host a live conference call and webcast on Monday, October 19, 2009 at 11:30 a.m. Eastern Daylight Time. The conference call will be hosted by Barry D. Quart, PharmD, Ardea’s president and chief executive officer, and Kimberly J. Manhard, Senior Vice President of Regulatory Affairs and Operations, and will include Mark C. Genovese, MD Professor of Medicine and Co-Chief of the Division of Immunology and Rheumatology at Stanford University Medical Center, and John S. Sundy, MD, PhD Associate Professor of Medicine and Head of the Section of Allergy and Clinical Immunology in the Division of Pulmonary, Allergy and Critical Care Medicine at Duke University Medical Center.
The conference call can be accessed by dialing 800-638-4930 for domestic callers and 617-614-3944 for international callers. Please use passcode: 94791770. The conference call and slide presentation will be webcast live under the investor relations section of Ardea's website at www.ardeabio.com, and will be archived there for 30 days following the call. Please connect to Ardea's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
surf1944
15 years ago
Ardea Biosciences to Present Results from a Phase 2a Study of RDEA594 at the 2009 ACR/ARHP Annual Scientific Meeting
Press Release
Source: Ardea Biosciences, Inc.
On Wednesday September 30, 2009, 8:30 am EDT
Companies:Ardea Biosciences, Inc.
SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that it will present results from a Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, at the 2009 American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania.
Previously disclosed interim results will be updated to include final single-agent cohort data, as well as data demonstrating RDEA594’s ability to lower serum urate to less than 6.0 mg/dL in patients with mild to moderate renal insufficiency, which was the majority of patients randomized to RDEA594. In addition, the company will provide an update on improved drug formulations and will present data from a preclinical drug-drug interaction study demonstrating RDEA594’s potential to be used in combination with allopurinol and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen), both of which lower serum urate via a different mechanism of action than RDEA594.
Presentation Details are as follows:
Poster Title: RDEA594, a Novel Uricosuric Agent, Significantly Reduced Serum Urate Levels and Was Well Tolerated in a Phase 2a Pilot Study in Hyperuricemic Gout Patients
Session Title: Treatment and Outcomes
Date/Time: Monday, October 19, 2009 from 9:00 AM – 6:00 PM Eastern Time
Presentation: Monday, October 19, 2009, 9:00 AM Eastern Time
Poster: 1105
Location: Pennsylvania Convention Center – Hall D
Poster Title: Evaluation of Drug-Drug Interaction Potential Between RDEA594, Allopurinol and Febuxostat in Preclinical Species
Session Title: Treatment and Outcomes
Date/Time: Monday, October 19, 2009 from 9:00 AM – 6:00 PM Eastern Time
Presentation: Monday, October 19, 2009, 9:00 AM Eastern Time
Poster: 1102
Location: Pennsylvania Convention Center – Hall D
About RDEA594 and RDEA684
RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, is a selective URAT1 transporter inhibitor that is in Phase 2 development as a single agent and in combination with the approved xanthine oxidase inhibitors, allopurinol and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen). Over 300 people have safely received RDEA594, either by direct administration or through administration of RDEA806, its prodrug. We have selected a next-generation URAT1 inhibitor, RDEA684, as a development candidate and expect to begin a Phase 1 study of RDEA684 in 2010. Based on preclinical results, RDEA684 demonstrates many of the same positive attributes as RDEA594, but with more than 170-times greater potency against the URAT1 transporter.
surf1944
15 years ago
Ardea Beats Zacks Estimate
By Zacks Equity Research
On Tuesday August 11, 2009, 1:40 pm EDT
Companies:Amgen Inc.Eli Lilly Co.Ardea Biosciences, Inc.
On Friday, Ardea Biosciences Inc. (NasdaqGM: RDEA - News) posted a second-quarter net loss of $8 million, or 44 cents per share, which was significantly lower than the Zacks Consensus Estimate of 60 cents per share. The company had reported a net loss of $15.7 million, or $1.10 per share in the year-ago period.
The narrower quarterly loss was attributable to the licensing payment from Bayer and lower expenses. Revenue of $5.5 million came from recognition of a part of the $35 million upfront payment under the Bayer agreement on development of MEK inhibitors for treatment of cancer and other indications. Ardea had registered no sales in the year-ago quarter.
Operating expenses for the quarter fell 19% to $13.2 million primarily on lower costs for discovery research since Ardea is concentrating its resources on development of its gout candidate, RDEA594, which is in mid-stage study. The decrease was partially offset by restructuring charges of about $0.7 million associated with the 47% work-force reduction.
About 3 million to 5 million people in the U.S. and approximately 5 million people in the European Union suffer from gout, which is the most common form of inflammatory arthritis in men over 40. The incidence and severity of gout is increasing in the United States. There was a 288% increase in gout-related hospitalizations from 1988 to 2005.
Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. This causes deposition of uric acid crystals in and around the connective tissue of the joints and in kidneys, leading to inflammation, formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares) and kidney damage (nephropathy).
However, we are concerned about Ardea’s weak pipeline. Moreover, since RDEA594 is still in early stages of development, it is associated with higher risks. The company will also face tough competition from big players like Amgen (NasdaqGS: AMGN - News), Eli Lily (NYSE: LLY - News) and Genentech (now part of Roche (Other OTC: RHHBY.PK - News)).
While the recently signed agreement with Bayer is a positive for the company as it strengthens its balance sheet dramatically, we remind investors that Ardea is still an early-stage development company and has a long way to go to bring any product into market.
surf1944
15 years ago
Ardea Biosciences Initiates Phase 2b Clinical Trial of RDEA594, Lead Product Candidate for the Treatment of Gout
RDEA684 Is Selected as Next-Generation Development Candidate for Treatment of Gout
Press Release
Source: Ardea Biosciences, Inc.
On Monday July 20, 2009, 8:00 am EDT
Companies:Ardea biosciences, inc.
SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq:RDEA - News) today announced that it has initiated a Phase 2b clinical trial of RDEA594, its lead product candidate in development for the management of hyperuricemia and gout. The Company also announced the selection of RDEA684, a next-generation URAT1 inhibitor, as a development candidate for the same indication.
The randomized, double-blind, placebo-controlled, dose-response study will evaluate the safety and serum urate-lowering effects of 200, 400 and 600 mg of RDEA594 in a total of 140 gout patients with hyperuricemia (uric acid levels of 8 mg/dL or more). The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0 mg/dL following four weeks of treatment. This study will be conducted at multiple sites in Europe and North America, with initial results expected by the end of 2009. The remaining studies in the planned Phase 2 program, including a Phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, a drug-drug interaction study with febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen), and a study in patients with renal impairment, are expected to begin shortly.
“Our Phase 2 program is designed to demonstrate RDEA594’s broad clinical potential in a wide spectrum of gout patients, including first-line use and as add-on therapy in patients not achieving an adequate response to either allopurinol or febuxostat, and in patients with varying degrees of renal impairment,” commented Barry D. Quart, Pharm.D., Ardea’s president and chief executive officer. “The FDA approval of febuxostat earlier this year and the recent recommendation by the FDA’s Arthritis Advisory Committee for approval of pegloticase (Krystexxa™, Savient Pharmaceuticals) for treatment-refractory gout has demonstrated the importance of new urate-lowering therapies for treatment of patients suffering from gout.”
About RDEA594 and RDEA684
RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, is a selective URAT1 transporter inhibitor that has successfully completed a Phase 2a proof-of-concept study in gout patients with hyperuricemia, as well as single- and multiple-ascending-dose Phase 1 studies in normal, healthy volunteers. Over 300 people have safely received RDEA594, either by direct administration or through administration of RDEA806, its prodrug. RDEA684, a next-generation URAT1 inhibitor, has been selected as a development candidate and has entered preclinical development in anticipation of a first-in-human clinical trial, which is expected to begin in 2010. Based on preclinical results, RDEA684 demonstrates many of the same positive attributes as RDEA594, but with more than 170-times greater potency against the URAT1 transporter.
surf1944
15 years ago
Ardea Bio Results Promising
By Grant Zeng, CFA
On Wednesday June 24, 2009, 2:57 pm EDT
Companies:Ardea biosciences, inc.
Ardea Biosciences' Gout Drug Shows Promising Results �
Positive results from phase II a and phase I trials
RDEA594 is Ardea Biosciences' (NasdaqGM: RDEA - News) lead drug candidate for the treatment of gout. The company recently announced positive interim results from an ongoing phase IIa, proof-of-concept study of RDEA594 for the treatment of hyperuricemia and gout, as well as additional positive results from completed phase I studies of RDEA594 in normal, healthy volunteers.
In late April 2009, the company initiated a placebo- and active-controlled, proof-of-concept study of RDEA594 in gout patients with hyperuricemia (uric acid = 8 mg/dL). This study is now fully enrolled and the majority of the 20 patients have completed the first week of dosing. Patients received RDEA594 200 mg once daily (QD) for the first week, followed by 400 mg QD for the second week. An immediate release (IR) capsule formulation, administered under fed conditions, was used in this study.
Of the first 7 patients randomized to RDEA594 to reach 8 days of dosing (first day after dose increased to 400 mg QD), 6 (86%) were responders, as defined by the achievement of target uric acid concentrations of less than 6 mg/dL. This compares to zero out of 4 patients randomized to placebo and 2 out of 3 patients randomized to a standard dose of allopurinol (300 mg QD) to reach 8 days of dosing.
On average, RDEA594-treated patients achieved a 40% reduction in serum urate levels by this early time point. Dosing in this phase IIa study is expected to be completed in late June 2009, with full results to be presented at an upcoming scientific conference. RDEA594 has been well tolerated in this study, with no serious adverse events and no premature discontinuations due to adverse events.
RDEA also presented two completed, randomized, double-blind, placebo-controlled, phase I studies that included data from 98 adult male subjects, of which 76 received RDEA594 at doses from 5 mg to 600 mg for 1 to 10 days. Statistically significant, dose-dependent reductions in serum urate of up to 45% were demonstrated in the multiple-ascending-dose study, which evaluated QD doses of RDEA594 100 mg oral solution and 200 and 400 mg IR capsules given fasted or placebo over a 10-day dosing period.
Administration of the IR capsule with a standard breakfast, as done in the phase IIa study, improved the pharmacokinetic profile of the drug and increased the reduction in uric acid compared to fasted conditions. RDEA594 was well tolerated at all dose levels tested, including single doses of an oral solution up to 600 mg, multiple doses of the IR capsules up to 400 mg QD, and multiple doses of an experimental extended-release tablet up to 600 mg QD. Adverse events (AEs) were mild to moderate in severity with no change with increasing dose, and no serious adverse events or discontinuations due to AEs.
Larger phase IIb is planned
RDEA plans to initiate a comprehensive phase IIb program soon to demonstrate the broad clinical utility of RDEA594 in the treatment of hyperuricemia and gout. Initial results should be available in 4Q09.
An estimated 3-5 million people in the United States -- and approximately 5 million people in the European Union -- suffer from gout, which is the most common form of inflammatory arthritis in men over 40. The incidence and severity of gout is increasing in the United States. There was a 288% increase in gout-related hospitalizations from 1988-2005.
Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. These abnormally elevated levels lead to the deposition of uric acid crystals in and around the connective tissue of the joints and in the kidneys, leading to inflammation, the formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares) and kidney damage (nephropathy).
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surf1944
16 years ago
Ardea Biosciences to Present Preclinical and Phase 1 Data on its Lead Gout Product Candidate, RDEA594, at the Annual European Congress of Rheumatology
On Monday May 18, 2009, 8:30 am EDT
SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that it will present data from multiple Phase 1 studies of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Copenhagen, Denmark.
Data will be presented on the safety, pharmacokinetics and uric acid-lowering effects of the administration of single-, and multiple-ascending-doses of RDEA594 in normal healthy volunteers, as well as data from studies designed to assess the potential for drug-drug interactions with RDEA594 and other renally-cleared drugs.
Presentation details are as follows:
Date/Time: Thursday, June 11, 2009 from 11:45 AM – 1:30 PM CET
Poster Title: Safety, Pharmacokinetics, and Serum Uric Acid Lowering Effect of
RDEA594, A Novel Uricosuric Agent, In Healthy Volunteers
Abstract Number: THU0451
Location: Bella Center Copenhagen – Poster Area
Date/Time: Thursday, June 11, 2009 from 11:45 AM – 1:30 PM CET
Poster Title: RDEA594: A Potent URAT1 Inhibitor Without Affecting Other Important
Renal Transporters, OAT1 and OAT3
Abstract Number: THU0452
Location: Bella Center Copenhagen – Poster Area
About RDEA594
RDEA594 is our lead product candidate for the treatment of hyperuricemia and gout. RDEA594 is an inhibitor of the URAT1 transporter in the kidney, which is responsible for the regulation of uric acid levels. Over 300 people have safely received RDEA594, either by direct administration or through administration of RDEA806, its prodrug.
surf1944
16 years ago
Ardea Biosciences and Bayer HealthCare Enter into Global Agreement Focused on the Development of MEK Inhibitors for the Treatment of Cancer
On Tuesday April 28, 2009, 8:30 am EDT
Ardea Biosciences, Inc.
SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq:RDEA - News) today announced that it has entered into a global agreement with Bayer HealthCare focused on the development of small molecule mitogen-activated ERK kinase (MEK) inhibitors for the treatment of cancer. The lead compound in this program, RDEA119, is currently being evaluated in advanced cancer patients as a single agent in a Phase 1 study and in a Phase 1/2 study in combination with sorafenib (Nexavar®, Onyx Pharmaceuticals, Bayer HealthCare).
Under the terms of the agreement, Ardea will grant Bayer a worldwide, exclusive license to develop and commercialize Ardea’s MEK inhibitors for all indications. Potential payments to Ardea under the agreement could total up to $407 million, not including royalties. This amount includes an upfront cash payment to Ardea of $35 million, as well as additional cash payments upon achievement of certain development, regulatory and sales-based milestones. Ardea is also eligible to receive low double-digit royalties on sales of products under the agreement.
Ardea will be responsible for the completion of the Phase 1 and Phase 1/2 studies currently being conducted for RDEA119. Thereafter, Bayer will be responsible for the further development and commercialization of RDEA119 and any of Ardea’s other MEK inhibitors. The agreement announced today is subject to all necessary authorizations, consents or clearances of governmental authorities.
“RDEA119 has demonstrated compelling synergistic activity in vitro in combination with sorafenib, as well as other approved anti-cancer agents, and we look forward to working with Bayer as a globally successful company in the field of targeted anti-cancer therapies to evaluate multiple drug combinations in several cancer indications,” commented Barry D. Quart, Ardea’s president and chief executive officer.
“We are very excited about the potential use of MEK inhibitors to treat a broad range of cancer indications,” stated Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. “We are looking forward to working with Ardea’s team on the development of novel cancer treatments for patients.”
About RDEA119, RDEA436 and Ardea’s Other MEK Inhibitors
RDEA119, a non-ATP competitive, highly-selective MEK inhibitor for the treatment of cancer and inflammatory diseases, is Ardea's lead compound from its MEK inhibitor research and development program. MEK is believed to play an important role in cancer cell proliferation, apoptosis and metastasis, as well as inflammation. Preclinical and clinical results suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and limited retention in the brain, which, in turn, may result in a reduced risk of central nervous system (CNS) side effects. Ardea has also designed a portfolio of next generation MEK inhibitors from chemical classes that are distinct from the RDEA119 chemical class. The most advanced of these compounds is RDEA436, which has been evaluated in a human micro-dose pharmacokinetic study.
surf1944
16 years ago
Ardea Biosciences to Present Preclinical Multi-Drug Combination Synergy Data on its Lead MEK Inhibitor, RDEA119, at the American Association for Cancer Research 100th Annual Meeting
Friday March 20, 8:30 am ET
SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq:RDEA - News) today announced that the Company will present data from preclinical studies of RDEA119, its lead mitogen-activated ERK kinase (MEK) inhibitor in development for the treatment of cancer, demonstrating synergy when administered in combination with multiple anti-cancer agents, at the American Association for Cancer Research 100th Annual Meeting 2009 in Denver, Colorado. Presentation Details are as follows:
Date/Time: Tuesday, April 21, 2009 from 8:00 AM – 12:00 PM Mountain Time
Session Title: Kinase Inhibitors 2
Poster Title: The Selective MEK Inhibitor RDEA119: Synergy with Multiple Classes of Anti-Cancer Agents
Abstract Number: 3700
Location: Hall B-F, Poster Section 35
About RDEA119
RDEA119, a non-ATP competitive, highly-selective MEK inhibitor for the potential treatment of cancer and inflammatory diseases is the Company's lead compound from its MEK inhibitor research and development program. RDEA119 has shown potential as a potent inhibitor of MEK, which is believed to play an important role in cancer cell proliferation, apoptosis and metastasis as well as inflammation. Preclinical and clinical results suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and limited retention in the brain, which, in turn, may result in a reduced risk of central nervous system (CNS) side effects. RDEA119 is currently being evaluated in a Phase 1/2 study in combination with sorafenib (Nexavar®, Onyx Pharmaceuticals, Bayer HealthCare) and as a single agent in a Phase 1 study, both in advanced cancer patients.
surf1944
16 years ago
Ardea Biosciences to Present Data on Gout and Inflammation Programs at the 2008 ACR/ARHP Annual Scientific Meeting
Tuesday September 16, 8:00 am ET
SAN DIEGO, Sept. 16 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) announced today that the Company will present preclinical data on RDEA594, its lead product candidate for the treatment of gout, as well as preclinical data on RDEA119,its lead mitogen-activated ERK kinase (MEK) inhibitor for the treatment of inflammation associated with gouty arthritis, at the 2008 American College of American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in San Francisco, California.
Presentation Details are as Follows:
Date/Time: Sunday, October 26, 2008, 9:00 a.m. - 11:00 a.m. PDT
Abstract Title: RDEA594, A Potential Uric Acid Lowering Agent through
Inhibition of Uric Acid Reuptake, Shows Better
Pharmakokinetics than its Prodrug RDEA806
Abstract Number: 28
Session Name: Crystal Associated Arthropathies
Location: Hall A, Poster Board 28
Date/Time: Tuesday, October 28, 2008, 2:45 p.m. - 3:00 p.m. PDT
Abstract Title: MEK Inhibitor RDEA119 Suppresses Inflammatory Cytokine
Production Induced by Monosodium Urate Crystals
Abstract Number: 1942
Session Name: Crystal Associated Arthropathies
Location: Room 104
surf1944
16 years ago
Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial
Thursday August 21, 8:00 am ET
SAN DIEGO, Aug. 21 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has authorized a Phase 1 study evaluating RDEA594 in normal healthy volunteers. RDEA594 is the Company's lead product candidate for the treatment of gout.
"Regulatory clearance for us to proceed with our Phase 1 study of RDEA594, within six months from designation as a clinical candidate is a testament to the efficiency of our development organization, and the importance we place on our gout program -- a program we intend to expand with second-generation compounds from our exciting ongoing research in this area," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "Earlier this quarter, we initiated a Phase 2a proof-of-concept study of RDEA806, a prodrug of RDEA594, which should allow us to provide an early confirmation of RDEA594's activity in the target population of patients with gout."
This Phase 1, randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, pharmacokinetics and uric acid lowering effects of single ascending oral doses of RDEA594 in healthy adult male volunteers.
About Gout
An estimated 3-5 million people in the United States, and approximately 5 million people in the European Union, suffer from gout, which is the most common form of inflammatory arthritis in men over 40. Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. These abnormally elevated levels lead to the deposition of uric acid crystals in and around the connective tissue of the joints and in the kidneys, leading to inflammation, the formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares), and kidney damage (nephropathy). While gout is a treatable condition, there are limited treatment options and a number of adverse effects are associated with current therapies. No new therapies have been approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years
About RDEA594
RDEA594, our lead product candidate for the treatment of gout, is a major metabolite of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in clinical development for the treatment of HIV. RDEA594 does not have antiviral activity and is believed to be responsible for the uric acid-lowering effects observed following administration of RDEA806 to over 100 subjects in Phase 1 and Phase 2 clinical trials. In Phase 1 studies of RDEA806 in normal healthy volunteers, increased urinary excretion of uric acid was observed in the first 24 hours after dosing, with statistically significant, exposure-dependent, decreases in serum uric acid of 35% to 50% observed during multiple dosing out to 14 days.
About RDEA806
RDEA806 is a novel NNRTI for the potential treatment of HIV infection. Based on preclinical and clinical studies to date, we believe that RDEA806 may have important competitive advantages compared to currently available NNRTIs. These include the potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz (Sustiva®) and other currently available NNRTIs; a high genetic barrier to resistance; limited pharmacokinetic interactions with other drugs; no reproductive toxicity based on animal studies; and the potential to be readily co-formulated in a single pill with other HIV antiviral drugs, such as Truvada® (emtricitabine and tenofovir) from Gilead Sciences, Inc, which is important for patient compliance.
surf1944
16 years ago
Ardea Biosciences Presents Phase 2a Antiviral Activity Data for Lead HIV Candidate, RDEA806 at XVII International AIDS Conference
Thursday August 7, 3:30 pm ET
MEXICO CITY and SAN DIEGO, Aug. 7 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that data was presented from its completed Phase 2a proof-of-concept monotherapy study of RDEA806, the Company's novel investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for patients with human immunodeficiency virus (HIV), demonstrating robust antiviral activity with a well-tolerated profile. An oral presentation of the data was given today by Dr. Graeme Moyle, Director of HIV Research, Chelsea and Westminster Hospital, during a late breaker session at the XVII International AIDS Conference in Mexico City.
"We are extremely pleased that the final results of the Phase 2a study presented today demonstrate that 800 mg once daily produced similar viral load reductions as 400 mg twice daily, providing final confirmation that RDEA806 works equally well given either once or twice daily. Based on the data to date, we continue to believe that RDEA806 has the potential to be a first-line therapy for the treatment of HIV," said Barry D. Quart, PharmD, Ardea's President and CEO. "We look forward to further evaluating RDEA806 and are on track to begin a Phase 2b study comparing once daily doses of RDEA806 to efavirenz (SUSTIVA®, Stocrin®) in first-line patients receiving background treatment with Truvada® (emtricitabine and tenofovir disoproxil fumarate), in the third quarter of this year. A recently completed drug interaction study with RDEA806 and Truvada confirmed the lack of drug-drug interactions between these agents, paving the way for initiation of the Phase 2b study."
The Phase 2a randomized, double-blind, placebo-controlled trial evaluated the antiviral activity, pharmacokinetics, safety and tolerability of once- and twice-daily oral dosing regimens of RDEA806 versus placebo in 48 HIV-positive patients who were naive to antiretroviral treatment. Nine out of 12 patients in each of four cohorts received RDEA806. The primary efficacy end point was the change from baseline in plasma viral load. Results from all four cohorts showed a median reduction in plasma viral load at nadir of 1.8 - 2.0 log copies/mL. There were no serious adverse events, premature discontinuations, clinically relevant ECGs changes or drug-related rash reported in any cohort. The incidence of CNS side effects was similar between drug and placebo. Gastrointestinal side effects were most common, but these effects were generally transient and mild.
The presentation is available on the conference website (http://www.aids2008.org) and on the Company website (http://www.ardeabio.com) under the title "Antiviral activity of RDEA806, a novel HIV non-nucleoside reverse transcriptase inhibitor, in treatment of naive HIV patients."
surf1944
16 years ago
Ardea to Present Data on Lead HIV Candidate, RDEA806, at XVII International AIDS Conference
Thursday July 17, 8:00 am ET
SAN DIEGO, July 17 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that Dr. Graeme Moyle, Director of HIV Research, Chelsea and Westminster Hospital, will present results from the Phase 2a proof-of-concept monotherapy study of RDEA806, during an oral presentation at a late breaker session of the XVII International AIDS Conference in Mexico City on August 7, 2008. RDEA806 is the Company's novel investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for patients with human immunodeficiency virus (HIV).
Presentation Details
Date/Time: Thursday, August 7, 2008 from 2:30 p.m. - 4:00 p.m. CDT
Abstract Title: "Antiviral activity of RDEA806, a novel HIV non-nucleoside
reverse transcriptase inhibitor, in treatment of naive HIV patients"
Session Title: THAB04 - Late Breaker Track B, Session 2
Location: Centro Banamex -- Session Room 1 (Abstract #THAB0403)
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout. We have four drug candidates in clinical trials and others in preclinical development and discovery. Our most advanced development candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it as a development candidate. RDEA594, our lead development candidate for the treatment of gout, is in preclinical development and is believed to be an inhibitor of the URAT1 transporter in the kidney, which is responsible for regulation of uric acid levels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients, as well as in a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it as a development candidate.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the results of preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, and costs associated with our drug discovery and development programs and business development activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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