CUPERTINO, Calif., Nov. 6, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) announced today that it will host a key
opinion leader (KOL) conference call and live webcast to discuss
the results of its recently completed Phase 2a clinical trial of
DUR-928 in patients with alcoholic hepatitis (AH) on Tuesday, November 12 at 12:00 noon EST. The call will feature a review of the
late-breaking oral presentation that Tarek
I. Hassanein, M.D. will deliver at The Liver
Meeting® 2019 at 8:30 a.m. EST on Tuesday, November 12.
Dial-In and Webcast Information
Tuesday, November 12 at 12 noon EST
Domestic (Free): 1-877-407-0784
Toll / International: 1-201-689-8560
Conference ID: 13696593
Webcast with slides:
http://public.viavid.com/index.php?id=137023
A replay of the webcast and data slide presentation will be
available on the Investor section of the DURECT website at
https://investors.durect.com/ after the call.
Dr. Tarek I. Hassanein is one of
the investigators of the Phase 2a AH clinical trial and is
board-certified in internal medicine, gastroenterology and
transplant hepatology. He is currently a professor of medicine and
director of outreach services for liver transplantation at the
School of Medicine, University of California
San Diego (UCSD). He has been instrumental in
establishing three major liver transplantation programs. Dr.
Hassanein established the Southern California Liver Centers in 2009
to care for patients with advanced and complicated liver diseases,
including alcoholic hepatitis, liver cancer, HCV and cirrhosis. He
is also the director of the Southern California Research Center,
medical director of UCSD Sharp Liver Transplant Outreach Program
and chief of gastroenterology and hepatology at Sharp Coronado
Hospital in Coronado, California.
Dr. Hassanein has been the principal investigator on multiple
international trials and has authored numerous publications. Dr.
Hassanein earned his medical degree from Alexandria University in Alexandria, Egypt. He completed his residency
training at Wayne State University in
Detroit, Michigan, and a research
fellowship and a clinical fellowship in gastroenterology,
hepatology and transplantation at the University of Pittsburgh School of Medicine.
About the DUR-928 Alcoholic Hepatitis Phase 2a
Trial
Patients with moderate and severe AH were treated with DUR-928,
administered intravenously, in this open label, dose escalation
multi-center U.S., Phase 2a clinical trial. Final enrollment
was 19 patients and comprised of: 8 patients (4 moderate and 4
severe) dosed at 30 mg, 7 patients (3 moderate and 4 severe) dosed
at 90 mg and 4 patients (4 severe) dosed at 150 mg. The study
objectives included assessment of safety, pharmacokinetics (PK) and
pharmacodynamic (PD) signals, including liver chemistry and
biomarkers.
About DURECT Corporation
DURECT is a
biopharmaceutical company actively developing therapeutics based on
its Epigenetic Regulator Program and proprietary drug delivery
platforms. DUR‑928, a new chemical entity in Phase 2 development,
is the lead candidate in DURECT's Epigenetic Regulator Program. An
endogenous, orally bioavailable small molecule, DUR-928 has been
shown in preclinical studies to play an important regulatory role
in lipid homeostasis, inflammation, and cell survival. Human
applications may include acute organ injury such as AH and acute
kidney injury (AKI), chronic hepatic diseases such as NASH, and
inflammatory skin conditions such as psoriasis and atopic
dermatitis. DURECT's advanced oral and injectable delivery
technologies are designed to enable new indications and enhanced
attributes for small-molecule and biologic drugs. Key product
candidates in this category include POSIMIR®
(bupivacaine extended-release solution), an investigational
locally-acting, non-opioid analgesic intended to provide up to 3
days of continuous pain relief after surgery, and a long-acting
injectable SABER-based HIV investigational product being developed
with Gilead. For more information about DURECT, please visit
www.durect.com.
DURECT Forward-Looking Statement
The statements in
this press release regarding the potential benefits and uses of
DURECT's drug candidates, including, but not limited to, the
potential use of DUR-928 to treat AH, hepatic and renal diseases
such as NASH and AKI, and inflammatory skin conditions such as
psoriasis and atopic dermatitis, the potential use of POSIMIR to
treat post-operative pain, planned clinical trial announcements for
the Phase 2a trial of DUR-928 in psoriasis in 2019, and the
potential development of a long-acting injectable SABER-based HIV
product with Gilead and associated potential payments to DURECT are
forward-looking statements involving risks and uncertainties that
can cause actual results to differ materially from those in such
forward-looking statements. Potential risks and uncertainties
include, but are not limited to, the risk of delays in clinical
trials or adverse safety events from patients administered with
DUR-928, the risk that the ongoing clinical trials of DUR-928 in
NASH or psoriasis do not successfully achieve their endpoints, the
risk that placebo controlled studies of DUR-928 required for
regulatory approval will not replicate results from open
label clinical trials or trials with small numbers of patients or
historical controls, the risks that the long-acting injectable
SABER-based HIV investigational product being developed with Gilead
will not succeed or that Gilead will abandon this program, the risk
that the FDA Advisory Committee will not recommend approval of
POSIMIR or that the FDA will not approve POSIMIR, and the risk of
delays and costs due to additional work or other requirements
imposed by regulatory agencies for continued development, approval
or sale of any of our product candidates. Further information
regarding these and other risks related to DURECT is included in
DURECT's Form 10-Q filed on November 5,
2019 under the heading "Risk Factors" and in subsequent
reports that we file with the Securities and Exchange
Commission.
NOTE: POSIMIR® and SABER® are
trademarks of DURECT Corporation. DUR-928 and POSIMIR are drug
candidates under development and have not been approved for
commercialization by the U.S. Food and Drug
Administration or other health authorities.
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SOURCE DURECT Corporation