CUPERTINO, Calif., March 29, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced it will host a key
opinion leader (KOL) call on the treatment of alcoholic hepatitis
(AH) on Thursday, April 5 at
11:00 a.m. Eastern Time.
The call will feature a presentation by KOL Paul Kwo, MD, who
will present an overview of alcoholic hepatitis, including an
overview of the disease and its progression, current treatment
options and new treatments in development for alcoholic hepatitis.
Dr. Kwo will be available to answer questions at the
conclusion of the call.
DURECT's management team will also provide an overview of the
Company's ongoing clinical development program for DUR-928,
including a summary of preclinical and clinical data disclosed
to-date and a review of the Company's Phase 2 study in patients
with alcoholic hepatitis. DUR-928 is the lead product
candidate in DURECT's Epigenetic Regulator Program. It is an
endogenous, first-in-class small molecule that has been shown in
nonclinical studies to modulate the activity of nuclear receptors
playing an important regulatory role in lipid homeostasis,
inflammation, and cell survival.
Dr. Paul Kwo is currently
Professor of Medicine of Gastroenterology and Hepatology, and
Director of Hepatology at 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 has
distinguished himself in the field of Hepatitis C therapeutics and
has been the principal investigator on multiple international
trials. He recently authored the ACG Clinical Guideline: Evaluation
of Abnormal Liver Chemistries. Dr. Kwo has extensively published on
the topics of the management and treatment of hepatitis B and C and
liver transplant. He is currently on the Editorial Board of
the Journal of Clinical Gastroenterology, and an active committee
member for the American Association for the Study of Liver Diseases
(AASLD).
Dial-In &
Webcast Information
|
Thursday, April
5 @ 11:00 am Eastern Time / 8:00 am Pacific Time
|
Domestic:
|
888-394-8218
|
International:
|
323-794-2149
|
Conference
ID:
|
7990605
|
Webcast
w/Slides:
|
http://public.viavid.com/index.php?id=128731
|
About DURECT
DURECT is a biopharmaceutical company
actively developing new 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, hepatic and renal
diseases such as nonalcoholic steatohepatitis (NASH) and PSC, 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. One late-stage
product candidate in this category is POSIMIR®
(SABER®-Bupivacaine), an investigational locally-acting,
non-opioid analgesic intended to provide up to 3 days of continuous
pain relief after surgery. Another late stage product
candidate is REMOXY® ER (oxycodone), an investigational
pain control drug based on DURECT's ORADUR® technology,
for which the FDA has set a PDUFA target action date of
August 7, 2018. In addition,
for the assignment of certain patent rights, DURECT may receive a
milestone payment upon NDA approval and single digit sales-based
earn-out payments from U.S. net sales of Indivior's RBP-7000
investigational drug for schizophrenia, for which Indivior has
submitted an NDA and for which the FDA has set a PDUFA target
action date of July 28, 2018.
For more information, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in
this press release regarding the KOL call, the potential benefits
and uses of drug candidates, including the potential use of DUR-928
to treat alcoholic hepatitis, PSC, NASH and other hepatic and
renal diseases, acute organ injury or inflammatory skin conditions
such as psoriasis and atopic dermatitis, POSIMIR to treat
post-surgical pain, REMOXY ER to treat pain, Indivior's RBP-7000 to
treat schizophrenia, and the potential milestone payment and
earn-out payments receivable from Indivior, 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 risks that the NDA submissions of RBP-7000 and
REMOXY ER will not result in product approvals, as well as possible
adverse events associated with the use of POSIMIR, REMOXY ER,
RBP-7000 and DUR-928, delays and costs due to additional work or
other requirements imposed by regulatory agencies for continued
development, approval or sale of POSIMIR, REMOXY ER and DUR-928,
and the possibility that studies of DUR-928 and POSIMIR will not
replicate results from earlier clinical trials. Further
information regarding risks related to DUR-928, POSIMIR, REMOXY ER
and RBP-7000 and other risks related to DURECT is included in
DURECT's Form 10-K filed on March 8,
2018 under the heading "Risk Factors."
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SOURCE DURECT Corporation