CUPERTINO, Calif., April 27, 2023 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced it will host a Key Opinion Leader
("KOL") event on Alcohol-Associated Hepatitis on May 16th in New York
City. Topics of discussion will include the etiology and
prevalence of alcohol-associated hepatitis (AH), current treatment
insufficiencies and unmet need for patients with AH, biology of
larsucosterol, trial design and status update for the Phase
2b AHFIRM trial in AH, and a company
update on regulatory and commercial efforts ongoing for
larsucosterol in AH. In addition to company management, two KOLs
will provide their expert opinions on alcoholic liver disease and
larsucosterol:
- Dr. Brett Fortune, Medical
Director, Liver Transplant Program, and Associate Professor of
Medicine at Montefiore Einstein.
- Dr. Paul Gaglio, Professor of
Medicine (in Surgery) and director of Hepatology Outreach at
NY-Presbyterian Hospital, Columbia
University Irving Medical Center.
DURECT's KOL Event will also be broadcast online and can be
accessed via the following:
Tuesday, May 16 @
12:00pm Eastern Time / 9:00am Pacific Time
Webcast:
https://www.webcaster4.com/Webcast/Page/359/48320
The webcast links will also be available by accessing DURECT's
homepage at www.durect.com and clicking on "Events" under the
"Investors" section. A replay will be available following the
conclusion of the event.
About Larsucosterol (DUR-928)
Larsucosterol is an endogenous sulfated oxysterol and an
epigenetic regulator. Epigenetic regulators are compounds that
regulate patterns of gene expression without modifying the DNA
sequence. DNA hypermethylation, an example of epigenetic
dysregulation, results in transcriptomic reprogramming and cellular
dysfunction, and has been found to be associated with many acute
(e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA
methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation,
which subsequently regulates expression of genes that are involved
in cell signaling pathways associated with stress responses, cell
death and survival, and lipid biosynthesis. This may ultimately
lead to improved cell survival, reduced inflammation, and decreased
lipotoxicity. As an epigenetic regulator, the proposed mechanism of
action provides further scientific rationale for developing
larsucosterol for the treatment of acute organ injury and certain
chronic diseases.
About DURECT Corporation
DURECT is a biopharmaceutical company committed to transforming
the treatment of acute organ injury and chronic liver diseases by
advancing novel and potentially lifesaving therapies based on its
endogenous epigenetic regulator program. Larsucosterol (also known
as DUR-928), DURECT's lead drug candidate, binds to and inhibits
the activity of DNA methyltransferases (DNMTs), DNA-modifying
enzymes that are elevated and associated with the hypermethylation
found in patients with severe alcohol-associated hepatitis (SAH).
Larsucosterol is in clinical development for the potential
treatment of SAH, for which FDA has granted a Fast Track
Designation. Non-alcoholic steatohepatitis (NASH) 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 has been exclusively licensed to Innocoll Pharmaceuticals for
commercialization in the United
States. For more information about DURECT, please visit
www.durect.com and follow us on Twitter
https://twitter.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 use of larsucosterol for the treatment of AH, the
commercialization of POSIMIR by Innocoll, and the potential to
develop larsucosterol for AH, NASH or 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 risks that the AHFIRM trial takes longer to
conduct than anticipated due to COVID-19 or other factors, the risk
that ongoing and future clinical trials of larsucosterol do
not confirm the results from 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 it for the
treatment of AH even if the results of the AHFIRM trial are
successful, 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 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, 2022 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 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 (DUR-928) 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