CUPERTINO, Calif., Oct. 21, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) announced today that the results from
the recently completed Phase 2a study of DUR-928 in patients with
alcoholic hepatitis (AH) have been selected for an oral
presentation as part of the late-breaking session of The Liver
Meeting® 2019, the annual meeting of the American
Association for the Study of Liver Diseases (AASLD), taking place
on November 8-12, 2019, in
Boston. This late-breaking
abstract was one of only 29 late-breaking abstracts selected out of
a total of approximately 3,000 abstracts that were accepted for
presentation at the meeting. Additionally, the study results were
selected for inclusion in the 'Best of The Liver Meeting' summary
slide presentation in the alcohol-related liver disease category.
Tarek Hassanein, M.D., one of the
trial's principal investigators, will deliver the oral presentation
of the detailed trial results.
In a separate poster presentation, Craig
McClain, M.D., will present additional comparative data from
the Phase 2a clinical trial of DUR-928 and a control group from a
contemporaneous AH trial conducted at University of Louisville.
"We look forward to Drs. Hassanein and McClain's respective
presentations of the positive results of our recently completed
Phase 2a trial of DUR-928 in patients with alcoholic hepatitis at
this year's Liver Meeting, which is among the most prestigious
gatherings of scientists and health care professionals dedicated to
preventing and curing liver disease," said James E. Brown, President and Chief Executive
Officer of DURECT. "These compelling data provide strong rationale
for continued development, and we plan to initiate a Phase
2b study for this difficult-to-treat
and life-threatening condition next year."
Oral Late-Breaker Presentation Details:
Title: Safety and Efficacy of DUR-928: A Potential New
Therapy for Acute Alcoholic Hepatitis
Date: Tuesday, November 12,
2019
Time: 8:30 am Eastern Time
Location: Auditorium, Hynes Convention Center
Session Title: Late-Breaking Abstract Oral Session II
Presentation Type: Oral, Late-Breaker Session
Publication Number: LO9
Poster Presentation Details:
Title: DUR-928 Therapy of Acute Alcoholic Hepatitis: A
Pilot Study
Date: Sunday, November 10, 2019
Time: Noon – 2:00 pm Eastern Time
Location: Hynes Convention Center, Hall B
Presentation Type: Poster Presentation
Publication Number: 1376
About the DUR-928 Alcoholic Hepatitis Phase 2a
Trial
Patients with moderate and severe AH were treated with
intravenously administered DUR-928 in this open label, dose
escalation, multi-center, U.S., Phase 2a clinical trial. Final
enrollment was 19 patients 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, 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 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. 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, 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
This press release includes forward-looking statements,
including plans to conduct a Phase 2b
study of DUR-928 in patients with alcoholic hepatitis next year,
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 and the development
of a SABER-based HIV investigational product. These
forward-looking statements involve 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
commencement of the Phase 2b trial of
DUR-928 in AH, future trials of DUR-928 in AH may not yield
positive results, potential adverse effects arising from the
testing or use of DUR-928, the risk that the FDA may not approve
the POSIMIR NDA, our ability to meet milestones in the development
of an injectable SABER-based HIV investigational product and the
risk that Gilead will terminate the development of this product,
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-Q filed with the Securities and Exchange
Commission on August 2, 2019 under
the heading "Risk Factors."
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