CUPERTINO, Calif., Oct. 17,
2024 /PRNewswire/ -- DURECT Corporation (Nasdaq:
DRRX), a late-stage biopharmaceutical company pioneering the
development of epigenetic therapies to transform the treatment of
serious and life-threatening conditions such as acute organ injury,
today announce that it will deliver an oral and two poster
presentations at The Liver Meeting 2024, organized by the American
Association for the Study of Liver Diseases (AASLD), to be held
November 15-19, 2024 in San Diego, California.
The presentations will showcase additional data from DURECT's
completed Phase 2b trial evaluating
its lead asset, larsucosterol, for the treatment of
alcohol-associated hepatitis (AH). The data further support the
design of the Company's upcoming Phase 3 trial of larsucosterol in
AH, including the importance of timely treatment in clinical
outcomes.
Presentation details are as follow:
Oral Presentation:
Title: Effects of Timely
Treatment on Outcomes of Larsucosterol for Severe
Alcohol-associated Hepatitis (AHFIRM Trial)
Presentation Number: 198
Session: Abstract Parallel Sessions - PBC,
Alcohol-associated Hepatitis, Hepatitis B, Portal Hypertension,
Costs of Care
Date and Time: November 18,
12:15 - 12:30 pm PT
Presenter: Lance Stein,
Piedmont Healthcare, Atlanta, GA,
USA
Poster Presentations:
Title: A Balancing Act:
The Life-Saving Potential and Ethical Dilemmas of Liver
Transplantation as an Endpoint in Alcohol Associated Hepatitis
Trials
Presentation Number: 3040
Session: Abstract Poster - Alcohol-Associated Liver
Diseases: Clinical and Experimental
Date and Time: November 17,
1:00 PM-2:00 PM (posters will be
available from 8:00 AM - 5:00 PM
PT)
Presenter: Aparna Goel,
Stanford University Medical Center,
Stanford, CA, U.S.
Title: Drinking Behavior in the AHFIRM trial as measured
by Phosphatidyl Ethanol
Presentation Number: 3140
Session: Abstract Poster - Alcohol-Associated Liver
Diseases: Clinical and Experimental
Date and Time: November 17,
1:00 PM-2:00 PM (posters will be
available from 8:00 AM - 5:00 PM
PT)
Presenter: Steven Flamm,
Rush University, Chicago, IL, U.S.
About DURECT Corporation
DURECT is a late-stage
biopharmaceutical company pioneering the development of epigenetic
therapies that target dysregulated DNA methylation to transform the
treatment of serious and life-threatening conditions, including
acute organ injury. Larsucosterol, DURECT's lead drug candidate,
binds to and inhibits the activity of DNA methyltransferases,
epigenetic enzymes that are elevated and associated with
hypermethylation found in AH patients. Larsucosterol is in clinical
development for the potential treatment of AH, for which the FDA
has granted a Fast Track and a Breakthrough Therapy designation;
MASH is also being explored. In addition,
POSIMIR® (bupivacaine solution) for infiltration
use, a non-opioid analgesic utilizing the innovative
SABER® platform technology, is FDA-approved and is
exclusively licensed to Innocoll Pharmaceuticals for sale and
distribution in the United States.
For more information about DURECT, please
visit www.durect.com and follow us on X (formerly
Twitter) at https://x.com/DURECTCorp.
DURECT Forward-Looking Statements
This press release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, relating to: the potential benefits
of Breakthrough Therapy designation, and the potential uses and
benefits of laruscosterol in patients with AH and potentially other
indications. Actual results may differ materially from those
contained in the forward-looking statements contained in this press
release, and reported results should not be considered as an
indication of future performance. The potential risks and
uncertainties that could cause actual results to differ from those
projected include, among other things, the risk that future
clinical trials of larsucosterol are delayed or do not confirm the
results from subset analyses of the AHFIRM trial, including
geographic or other segmentation, or of earlier clinical or
pre-clinical trials, or do not demonstrate the safety or efficacy
of larsucosterol in a statistically significant manner; the risk
that the FDA or other government agencies may require additional
clinical trials for larsucosterol before approving larsucosterol
for the treatment of AH, the risk that Breakthrough Therapy
designation does not expedite the process for FDA approval and that
larsucosterol may never be approved; risks that Innocoll may not
commercialize POSIMIR successfully; and risks related to the
sufficiency of our cash resources, our anticipated capital
requirements, our need or desire for additional financing, our
ability to continue to meet the minimum bid price for continued
listing on Nasdaq, our ability to obtain capital to fund our
operations and expenses, and our ability to continue to operate as
a going concern. Further information regarding these and other
risks is included in DURECT's most recent Securities and Exchange
Commission (SEC) filings, including its annual report on Form 10-K
for the year ended December 31, 2023
and quarterly report on Form 10-Q for the quarter ended
June 30, 2024, under the heading
"Risk Factors." These reports are available on our website
www.durect.com under the "Investors" tab and on the SEC's website
at www.sec.gov. All information provided in this press release and
in the attachments is based on information available to DURECT as
of the date hereof, and DURECT assumes no obligation to update this
information as a result of future events or developments, except as
required by law.
NOTE: POSIMIR® is a trademark of Innocoll
Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT
Corporation outside of the U.S. SABER® is a trademark of
DURECT Corporation. Other referenced trademarks belong to their
respective owners. Larsucosterol is an investigational drug
candidate under development and has not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities for any indication.
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SOURCE DURECT Corporation
