CUPERTINO, Calif., March 27, 2019 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced it has commenced patient enrollment
in a Phase 1b trial with oral DUR-928
in patients with NASH. DUR-928, the lead investigational
product in the Company's Epigenetic Regulator Program, is an
endogenous, first-in-class small molecule, which may have broad
applicability in chronic hepatic diseases such as NASH, acute organ
injuries such as alcoholic hepatitis (AH) and acute kidney injury
(AKI), and in inflammatory skin disorders such as psoriasis and
atopic dermatitis.
"NASH is a complex medical condition for which multimodal
treatments are likely to be required to address the full range of
NASH patients," stated Dr. Brent Tetri, Professor of Internal
Medicine at Saint Louis University. "DUR-928 has been shown
to have an excellent safety profile to date. As an endogenous
molecule with a novel mechanism of action, it will be intriguing to
see what biological signals are generated in this multi-dose study
especially given what was previously reported in the single-dose
study."
"Commencing patient enrollment in this multi-dose NASH trial is
the third important milestone for DUR-928 so far in 2019," said
James E. Brown, President and CEO of
DURECT. "First we announced the advancement to the 90 mg dosing
cohort in severe AH patients in our AH trial based on encouraging
data in the 30 mg dosing cohorts, then commencement of dosing in
the psoriasis trial, and now enrollment for daily dosing of DUR-928
in patients with NASH. We look forward to multiple DUR-928 readouts
in 2019."
This is an open-label, Phase 1b
study, evaluating three doses of oral DUR-928 (low, middle and
high) administered daily for 28 consecutive days to evaluate
safety, pharmacokinetics and signals of biological activity in
patients with NASH. DURECT plans to enroll approximately 20
patients per dose group for a total of approximately 60 patients in
the trial. The trial is being conducted at multiple clinical sites
in the U.S. DURECT expects to announce initial data from this
study in the second half of 2019.
In the Company's previous Phase 1b
NASH study, reported at the European Association for the Study of
the Liver (EASL) in April 2017,
exploratory biomarker analysis demonstrated that a single oral dose
of DUR-928 in NASH patients, at both dose levels tested (50 mg and
200 mg), resulted in statistically significant reductions from
baseline of both full-length and cleaved cytokeratin-18 (CK-18),
bilirubin, hsCRP and IL-18.
Key Opinion Leader (KOL) Call
On Wednesday, April 17, 2019 at
11:00am EST/8:00am PST, DURECT will be hosting a key opinion
leader (KOL) call providing an overview of NASH and its
progression, current treatment options and new treatments in
development for NASH. The call will feature a presentation by KOL
Brent Tetri, MD, Professor of Internal Medicine at Saint Louis University. DURECT will also provide an
overview of the Company's development program for DUR-928 and Dr.
Tetri will be available to answer questions after the
presentations.
Dial-In & Webcast Information
Thursday, April 17 @
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 NASH
Non-alcoholic fatty liver disease (NAFLD) is the most common
form of chronic liver disease in both children and adults. It is
estimated that NAFLD affects about 20% to 30% of adults and 10% of
children in the United States.
NASH, a more severe and progressive form of NAFLD, is one of the
most common chronic liver diseases worldwide, with an estimated
prevalence of more than 10% of adults in the United States, Europe, Japan
and other developed countries. No drug is currently approved
for NAFLD or NASH.
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 the planned Phase
1b trial of DUR-928 in NASH patients,
the potential of DUR-928 to show positive signals of biological
activity in such trial, the potential use of DUR-928 to treat
chronic hepatic diseases such as NASH, acute organ injuries such as
alcoholic hepatitis (AH) and acute kidney injury (AKI), and in
inflammatory skin disorders such as psoriasis and atopic
dermatitis, the use of POSIMIR to treat post-surgical pain, the use
of Indivior's PERSERIS™ to treat schizophrenia, as well
as the potential commercial sales of Indivior's 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 NASH, AH
and mild to moderate plaque 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 will not
have a successful launch, 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