harlem111
2 days ago
Lexaria's GLP-1 Human Pilot Study #3 Begins Dosing AND TRHE PPS ???
October 09, 2024 9:05am EDT
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DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format
KELOWNA, BC / ACCESSWIRE / October 9, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has begun, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) Zepbound® (tirzepatide) in an oral dose format.
The Study is being conducted in up to 10 healthy volunteers. The initial seven day dosing phase of either an oral DehydraTECH-processed tirzepatide capsule or a single injected tirzepatide dose is scheduled to be completed on October 13th. After a multi-week washout period, the second (final) seven day dosing phase will be administered in mid-November where subjects will receive the alternate treatment condition than what was received during the initial dosing phase. No serious adverse events have been observed thus far during this initial dosing phase.
Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated in this Study. The DehydraTECH compositions for this Study were compound-formulated using commercially available Zepbound® injectable formulation as the tirzepatide input material.
Tirzepatide is currently approved for use in the USA under the brand names Zepbound® and Mounjaro®, owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024.
In two previous human pilot studies, Lexaria has evidenced that processing of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) with DehydraTECH and administered in an oral format, shows improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to the Rybelsus® tablet. The two drugs, semaglutide and tirzepatide are believed to comprise over 90% of all revenue generated in the GLP-1 sector today.
In pilot Study #3 referred to today, Lexaria is hopeful of evidencing meaningful absorption rates of tirzepatide in a swallowed oral format, which is not available in the market today since it is currently administered only by injection.
About the Study
Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide to be administered orally daily for seven days. The Zepbound® formulation has a strength of 2.5 mg tirzepatide to be administered once via injection with the subject monitored over the same seven day duration applicable with the oral DehydraTECH-tirzepatide condition. Blood samples will be taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with a final blood draw taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Single blood samples will also be taken daily on each of the second through eighth days following commencement of dosing. Up to ten healthy subjects are expected to be dosed with each test article following a randomized, cross over study design across two study phases.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
damAcon1
2 days ago
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ACCESSWIRE
Oct 09, 2024, 9:05 AM ET
DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format
KELOWNA, BC / ACCESSWIRE / October 9, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has begun, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) Zepbound® (tirzepatide) in an oral dose format.
The Study is being conducted in up to 10 healthy volunteers. The initial seven day dosing phase of either an oral DehydraTECH-processed tirzepatide capsule or a single injected tirzepatide dose is scheduled to be completed on October 13th. After a multi-week washout period, the second (final) seven day dosing phase will be administered in mid-November where subjects will receive the alternate treatment condition than what was received during the initial dosing phase. No serious adverse events have been observed thus far during this initial dosing phase.
Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated in this Study. The DehydraTECH compositions for this Study were compound-formulated using commercially available Zepbound® injectable formulation as the tirzepatide input material.
Tirzepatide is currently approved for use in the USA under the brand names Zepbound® and Mounjaro®, owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024.
In two previous human pilot studies, Lexaria has evidenced that processing of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) with DehydraTECH and administered in an oral format, shows improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to the Rybelsus® tablet. The two drugs, semaglutide and tirzepatide are believed to comprise over 90% of all revenue generated in the GLP-1 sector today.
In pilot Study #3 referred to today, Lexaria is hopeful of evidencing meaningful absorption rates of tirzepatide in a swallowed oral format, which is not available in the market today since it is currently administered only by injection.
About the Study
Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide to be administered orally daily for seven days. The Zepbound® formulation has a strength of 2.5 mg tirzepatide to be administered once via injection with the subject monitored over the same seven day duration applicable with the oral DehydraTECH-tirzepatide condition. Blood samples will be taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with a final blood draw taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Single blood samples will also be taken daily on each of the second through eighth days following commencement of dosing. Up to ten healthy subjects are expected to be dosed with each test article following a randomized, cross over study design across two study phases.
harlem111
3 days ago
Lexaria Updates Current GLP-1 Market
October 08, 2024 9:20am EDT
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KELOWNA, BC / ACCESSWIRE / October 8, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery technology, provides an update on recent glucagon-like peptide-1 ("GLP-1") receptor agonist market sector advancements.
In 2020 the total market size for GLP-1 drugs was less than $4 billion . That same year, Novo Nordisk® paid $1.8 billion to purchase Emisphere's® SNAC drug delivery technology which was subsequently incorporated into Rybelsus® semaglutide oral tablets, resulting in the first and only Food and Drug Administration ("FDA") approved GLP-1 drug for use as an oral tablet.
Today, the GLP-1 market is growing faster than nearly all historic forecasts had predicted. Bay Bridge Bio has published a useful interactive chart which highlights that, while there are a number of GLP-1 drug brands available today, over 95% of the current market is served by only two drugs : semaglutide (Wegovy®, Ozempic®, Rybelsus®) manufactured by Novo Nordisk®; and the dual action GLP-1 plus glucose-dependent insulinotropic polypeptide ("GIP") receptor agonist tirzepatide (Mounjaro®, Zepbound®) manufactured by Eli Lilly®. Combined revenue of these two drugs during Q2, 2024, was $11.04 billion compared to $5.89 billion in Q2, 2023, and just $2.55 billion during Q2, 2022. As a stark comparison, these drugs generated less than $300 million during the entire year of 2018.
Despite this unprecedented growth, GLP-1/GIP drugs currently delivered by oral tablet comprise only roughly 10% of the entire market dominated by injectable delivery. The share of the market addressed with oral tablets is likely to grow aggressively as patients are expected to migrate away from injections as more available oral forms become available. Lexaria expects that its DehydraTECH drug delivery system could be a global leader in GLP-1/GIP drug delivery as oral delivery dominates in the years to come.
Analysts around the world have been trying to keep up with GLP-1 trends. Compounding the difficulty in doing so is projecting which major pharmaceutical firms will achieve approval for GLP-1/GIP and related drugs currently in the development pipeline. Tirzepatide, for example, was only approved by the FDA in May, 2022, but Eli Lilly is forecasting $15 billion in revenue from the drug during calendar 2024.
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Expanding Applications For GLP-1 Drugs
The effects of GLP-1 drugs for weight loss and diabetes control are well known, but additional benefits are appearing outside of those original areas of investigation. For example, on March 8, 2024, the FDA approved Wegovy ® (semaglutide) "to reduce the risk of cardiovascular death, heart attack and stroke". A large study of 17,600 people evidenced that weekly semaglutide injections reduced those cardiovascular risks by ~20%.
Heart disease remains the #1 leading cause of death in America, resulting in 702,880 deaths in 2022 . The World Health Organization estimates that cardiovascular diseases cause 17.9 million deaths , globally, each year.
A meta-analysis of 12 studies that included ~73,000 patients has shown reduced harm experienced from chronic kidney disease when GLP-1 drugs were administered. In a large analysis of over 165,000 patients , type-2 diabetic patients with acute kidney disease receiving GLP-1 drugs evidenced lower mortality rates and lower incidences of both major cardiovascular events and major adverse kidney events, than those patients not receiving GLP-1 drugs.
Approximately 35 million people in the US have chronic kidney disease , according to the Center for Disease Control, and it is estimated that 1.2 million people around the world die each year from the disease.
Some of the latest research seems to indicate a connection between GLP-1 drugs and the human brain, wherein inflammation models including heart disease, atherosclerosis, and liver and kidney inflammation may be mediated through the brain.
Given that heart disease and kidney disease are so widespread, and with the latest analytical study data showing that GLP-1 drugs are improving health outcomes for patients with these diseases, it seems likely that, over time, GLP-1 drugs may be approved for additional therapeutic uses in patient populations that far exceed today's regulator-approved disease indications.
GLP-1/GIP and related drugs are already one of the fastest growing sectors in the history of the pharmaceutical industry. Given that these drugs are evidencing an expansion of their therapeutic applications and are expected to be approved by national drug regulators for expanded use; and given that health insurers are increasing their coverage for these drugs, it seems possible that current growth expectations of most analysts are conservative.
Lexaria has already provided evidence that DehydraTECH seems to provide improved drug delivery kinetics and improved blood sugar control with the world's leading GLP-1 drug: semaglutide. Lexaria's interest and focus on the GLP-1/GIP and related drug sector will continue for the foreseeable future with additional studies and evaluation.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
harlem111
1 week ago
New CFO is getting some shares etc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Item 5.02 Departure of Directors or Certain Officers; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Effective October 1, 2024, Michael Shankman, age 64, has been appointed to the position of Chief Financial Officer of Lexaria Bioscience Corp. (the “Company”) replacing Lexaria’s former CFO, Nelson Cabatuan who resigned effective July 15, 2024 and assuming the position of principal financial officer and principal accounting officer previously assumed by the Company’s CEO, Richard Christopher.
Mr. Shankman was previously engaged by the Company as an outsourced CFO via NowCFO from June 2023 to February 2024. Upon the effectiveness of Mr. Shankman’s appointment as Chief Financial Officer, Mr. Shankman also became the Company’s principal financial officer and principal accounting officer, and Richard Christopher, the Company’s Chief Executive Officer who assumed the responsibilities as the Company’s principal financial officer on an interim basis, relinquished those responsibilities to Mr. Shankman.
Mr. Shankman does not have any family relationships with any other person employed or engaged by the Company nor has Mr. Shankman been a party to any transaction with the Company exceeding $120,000.
Mr. Shankman is a Certified Public Accountant holding an MBA, Finance from California State University who previously worked with NowCFO from 2021 to 2024. During his time with NOW CFO, Mr. Shankman provided outsourced CFO and Controller services gaining extensive experience and familiarity with both public and private companies in a wide variety of industry fields. Prior to his engagement with NowCFO, Mr. Shankman worked for The Articom Group, being a $160M provider of refrigeration and HVAC design, installation, maintenance and repair services to national grocery chains, as its Corporate Controller from 2020-2021. And from 2019 to 2020 Mr. Shankman was the Controller for Change.Org a $35M public benefit corporation.
In his position as Chief Financial Officer, Mr. Shankman will be compensated with a base annual salary which will be subject to annual increases of 1.25 x the annual inflation rate as determined by the US Federal Reserve Board and annual performance milestone bonuses of up to 35% during the first year, 40% during the second year and thereafter up to 50% of the base salary. In accordance with the Agreement, on October 1, 2024, the Board granted Mr. Shankman an incentive stock option to purchase up to 50,000 shares of the Company’s common stock, pursuant to its Equity Incentive Plan (the “Options”). The Options have an exercise price per share equal to $3.17, being one cent ($0.01) above the closing price of the Company’s shares on the Nasdaq Capital Market on the grant date, and will vest commencing on February 28, 2025 as to 20,000 options, an additional 15,000 vesting on August 31, 2025 and the remaining 15,000 vesting on August 31, 2026.
Should Mr. Shankman be terminated without cause, after an initial six months with the Company, he will be entitled to severance pay equal to two (2) months base salary, with such severance pay increasing by a month for each completed year of employment.
The description of Mr. Shankman’s compensation is qualified in its entirety by the agreement that will be filed as an exhibit to the Company’s Annual 10-K Periodic Report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
LEXARIA BIOSCIENCE CORP.
Richard Christopher
CEO, Principal Executive Officer
Date: October 2, 2024
harlem111
1 week ago
Lexaria Appoints Michael Shankman as Chief Financial Officer
October 01, 2024 9:25am EDT
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KELOWNA, BC / ACCESSWIRE / October 1, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the appointment of Michael Shankman, CPA, as Chief Financial Officer (CFO) effective immediately. As a member of the executive leadership team, Mr. Shankman will lead the Company's financial operations.
"Mike is an accomplished individual who brings a wealth of financial and regulatory knowledge and experience to the table," said Richard Christopher, Chief Executive Officer of Lexaria. "On behalf of the entire Lexaria team, I'm thrilled to welcome Mike as our CFO as we continue to strengthen our executive team in expectations of strong growth into 2025."
Mr. Shankman has previously worked with Lexaria and assisted with its financial reporting and 2023 audit as a designated contractor and as such is deeply familiar with the Company. From 2021 to 2024 Mr. Shankman provided outsourced CFO and Controller services for a national service provider, gaining extensive experience and familiarity with both public and private companies in a wide variety of industry fields. Previously, Mr. Shankman held financial leadership positions with increasing responsibility in a variety of industries, including biotechnology, medical devices, and software as service.
"Lexaria seems to be on the cusp of terrific advancements and I couldn't be more enthusiastic about its prospects," said Mr. Shankman. "I'm excited to join the team and look forward to contributing to the Company's progress as it advances its pharmaceutical research and development program."
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
hdhick
2 weeks ago
Next frontier in anti-obesity landscape: oral GLP-1s with potential OTC switch
The race to develop oral obesity drugs is heating up. Eli Lilly (LLY) and Novo Nordisk (NVO), makers of the highly popular injectable GLP-1 class of weight loss drugs, as well as potential new entrants Pfizer (PFE) and Roche (OTCQX:RHHBY), are all in the fray.
Shortcomings of injectables have made oral GLP-1s a hotly pursued goal in the anti-obesity space. However, Oppenheimer went a step further, arguing in a research note on Wednesday that a potential switch to their over-the-counter status would be an added advantage.
“In an intensely competitive obesity landscape, Rx to OTC could be a highly differentiated, valuable life-cycle management strategy to preserve substantial brand equity well beyond patent expiry,” Oppenheimer analyst Jay Olson argued.
His comments followed a selloff in Novo Nordisk (NVO) shares on Friday after the Danish drugmaker said its cannabinoid receptor-targeting obesity pill raised concerns over neuropsychiatric side effects in a mid-stage study.
However, Olson rules out safety concerns for GLP-1s and predicts a future Rx-to-OTC switch for an oral GLP-1, attributing the current black box warning approved for the drug class to pancreatitis linked to first-generation GLP-1s such as exenatide but not newer GLP-1s.
Oppenheimer pointed to Viking Therapeutics (VKTX) oral weight loss candidate VK2735 as the best-positioned candidate to receive the Rx-to-OTC switch. The dual agonist of gut hormone receptors GLP-1 and GIP is set for an early-stage readout at Obesity Week in early November.
“We believe oral VK2735 is a potential candidate for OTC status based on existing clinical data and look forward to Obesity Week updates,” Olson wrote with an Outperform recommendation and a 12-18 month target of $138 per share.
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