CUPERTINO, Calif., May 3, 2019 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced that it will report preliminary data
from the ongoing DUR-928 alcoholic hepatitis (AH) trial and its
financial results for the three months ended March 31, 2019 after the market close on
Tuesday, May 7. The following
morning, Wednesday, May
8th at 8:30 a.m. Eastern
Time, DURECT will host a Key Opinion Leader (KOL) and
earnings conference call and webcast with slides.
During the webcast and conference call, DURECT management will
provide a corporate business update, including a presentation of
preliminary data from the ongoing Phase 2a open label, dose
escalation, multi-center U.S. clinical trial investigating DUR-928
administered intravenously in patients with moderate and severe AH.
The objectives of this study include assessment of safety, PK
and pharmacodynamic signals, including liver biochemistry and
biomarkers.
KOL Discussion on Alcoholic Hepatitis
Also participating in the call will be three Key Opinion Leaders on
alcoholic hepatitis: Drs. Steven
Flamm, Tarek Hassanein, and
Paul Kwo. Dr. Kwo will present
an overview of AH including details on the disease and its
progression, current treatment options and new treatments in
development. Drs. Hassanein and Flamm will discuss their experience
treating patients in the ongoing DUR-928 AH clinical trial.
Steven L. Flamm,
M.D. is a Professor of Medicine and Surgery with the
Division of Hepatology at Northwestern
University Feinberg School of Medicine. He also serves as
the Chief of Transplant Hepatology. Dr. Flamm has published widely
in the field of hepatic diseases and has spoken both nationally and
internationally on many other liver-related topics including viral
hepatitis, autoimmune hepatitis, hepatic encephalopathy, and liver
transplantation. He has an active clinical research program in
chronic viral hepatitis (HBV and HCV) and autoimmune hepatitis. Dr.
Flamm is a member of the American Gastroenterological Association
(AGA) and the American Association for the Study of Liver Diseases
(AASLD), where he recently served as the Chair of the AASLD
Development and Publication and Practice Guidelines Committee, as
well as the AASLD Foundation. He has also served as the Region 7
Representative to the UNOS Liver and Intestine Committee. Dr. Flamm
received his MD degree from the University of
Pennsylvania School of Medicine. He completed both a
clinical fellowship in gastroenterology and a research fellowship
in gastroenterology and hepatology at Beth Israel Hospital,
Harvard Medical School. He also
completed a clinical fellowship in hepatology and liver
transplantation at The Deaconess Hospital, Harvard Medical School before joining Northwestern University.
Tarek I. Hassanein,
M.D. is currently a Professor of Medicine at the School of
Medicine and Director of Outreach Services for Liver
Transplantation at the University of
California San Diego, Director of the Southern California
Research Center, Medical Director of the Southern California GI and
Liver Centers, and Medical Director, Gastroenterology Services and
Comprehensive Liver Care Services at Sharp Coronado Hospital in
Coronado, California. Dr.
Hassanein has been recognized for his work in gastroenterology and
has been the recipient of many awards and honors. He has been
the principal investigator on multiple international trials and has
been extensively published. He is a regular university,
television, and radio lecturer on gastroenterology and digestive
diseases. He is currently on the Editorial Board of
Hepatology and Gastroenterology, Digestive Diseases & Sciences,
Arab Journal of Gastroenterology, Egyptian Liver Cancer
Association, and a Reviewer for Hepatology, Journal of Hepatology,
Gastroenterology, American Journal of Gastroenterology, Digestive
Diseases and Sciences, Mayo Clinic Proceedings, Journal of Medical
Virology, Medical Principles and Practice, Cancer Investigation,
Oncology, International Neuropsychological Society, and Alimentary
Pharmacology & Therapeutics.
Paul Kwo, M.D. is
currently Professor of Medicine and Director of Hepatology at
the Stanford University where he joined
the faculty in November 2016.
Prior to joining the faculty at Stanford, he was at Indiana University for 21 years where he served as
the Medical Director of Liver Transplantation. He received
his MD from Wayne State University School of Medicine, his
Internal Medicine training at University of
Maryland, and his Gastroenterology/Hepatology training at
Mayo Clinic Rochester. He has served on numerous committees for
national and international societies. He has distinguished
himself in the field of chronic Hepatitis C and has served as the
PI for multiple seminal trials in the treatment of hepatitis C. He
is the author of the recent ACG Practice Guideline Evaluation
of Abnormal Liver Chemistries. He has won multiple awards,
both at the university, local, and national level.
Conference Call
and Webcast with Slides
|
Wednesday, May
8th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific
Time
|
Toll
Free:
|
888-882-4478
|
International:
|
323-794-2590
|
Conference
ID:
|
7156796
|
Webcast:
|
http://public.viavid.com/index.php?id=134476
|
A live audio webcast and data slide presentation will be
available by accessing DURECT's homepage at www.durect.com and
clicking "Investors." If you are unable to participate during
the live webcast, the call and slide presentation will be archived
on DURECT's website under "Event Calendar – Past Events" in the
"Investors" section.
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 Alcoholic Hepatitis (AH) and
acute kidney injury (AKI), chronic hepatic diseases such as
nonalcoholic steatohepatitis (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. Late stage 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 ORADUR®-Methylphenidate ER Capsules,
approved in Taiwan as Methydur
Sustained Release Capsules, where it is indicated for the treatment
of attention deficit hyperactivity disorder (ADHD). In
addition, for the assignment of certain patent rights, DURECT
receives single digit sales-based earn-out payments from U.S. net
sales of Indivior's PERSERIS™ (risperidone) drug for
schizophrenia, which was commercially launched in February
2019. For more information, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding DUR-928,
including regarding its clinical trial in AH patients and the
potential use of DUR-928 to treat AH, AKI, chronic hepatic diseases
such as NASH, and inflammatory skin disorders such as
psoriasis and atopic dermatitis, as well as statements regarding
the use of POSIMIR to treat post-surgical pain, the use of Methydur
to treat ADHD, and potential earn-out payments from U.S. sales of
PERSERIS, 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 the enrollment of the ongoing clinical trials of DUR-928 in AH,
NASH and psoriasis, potential adverse effects arising from the
testing or use of DUR-928, the risk that the FDA may not approve
the POSIMIR NDA, the risk that PERSERIS and Methydur will not have
successful launches, our ability to avoid infringing patents held
by other parties and secure and defend patents of our own patents,
and our ability to manage and obtain capital to fund our operations
and expenses. Further information regarding these and other risks
is included in DURECT's Form 10-K on March
8, 2019 under the heading "Risk Factors."
NOTE: ORADUR®, POSIMIR® and
SABER® are trademarks of DURECT Corporation.
Other referenced trademarks belong to their respective owners.
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. Full prescribing
information for PERSERIS, including BOXED WARNING, and Medication
Guide can be found at www.perseris.com.
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SOURCE DURECT Corporation