CUPERTINO, Calif., March 1, 2022 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced it dosed the first
patient in the European Union as part of its AHFIRM randomized,
double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of
larsucosterol in severe alcohol-associated hepatitis (AH)
patients.
"Dosing the first patient in Europe is an important milestone as we
continue to make progress in the AHFIRM trial," stated James E. Brown, D.V.M., President and CEO of
DURECT. "AH is a life-threatening disease in many regions of the
world and, accordingly, we now have clinical trial sites open
across the U.S., Australia, U.K.
and the E.U."
About the AHFIRM Trial
Enrollment is ongoing in our
Phase 2b randomized, double-blind,
placebo-controlled, international, multi-center study in subjects
with severe acute alcohol-associated hepatitis (AH) to
evaluate saFety and effIcacy of laRsucosterol
(DUR-928) treatMent (AHFIRM). The study is comprised of
three arms targeting enrollment of 300 total patients, with
approximately 100 patients in each arm: (1) Placebo plus standard
of care (SOC) which may include the use of methylprednisolone, a
corticosteroid, at the discretion of the treating physician; (2)
larsucosterol (30 mg); and (3) larsucosterol (90 mg). All
patients in the trial receive supportive care. The primary outcome
measure is 90-day survival rate for patients treated with
larsucosterol compared to those treated with placebo plus
SOC. The Company is targeting more than 60 clinical trial
sites across the U.S., EU, U.K., and Australia. Reflecting the life-threatening
nature of AH and the lack of therapeutic options, the U.S. Food and
Drug Administration (FDA) has granted larsucosterol Fast Track
Designation for the treatment of AH. We believe demonstration of a
robust survival benefit in the AHFIRM trial would support an NDA
filing. For more information, refer to ClinicalTrials.gov
Identifier: NCT04563026.
About alcohol-associated hepatitis (AH)
AH is a
life-threatening acute alcohol-associated liver disease (ALD) often
caused by chronic heavy alcohol use and a recent period of
increased alcohol consumption (i.e., a binge). It is characterized
by severe inflammation and destruction of liver tissue (i.e.,
necrosis), potentially leading to life-threatening complications,
including liver failure, acute renal injury and multi-organ
failure. There are no FDA approved therapies for AH and an analysis
of 77 studies published between 1971 and 2016, which included data
from a total of 8,184 patients, showed the overall mortality from
AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A
subsequent global study published in December 2021, which included 85 tertiary centers
in 11 countries across 3 continents, prospectively enrolled 2,581
AH patients with a median MELD score of 23.5, reported mortality at
28 and 90 days of 20% and 30.9% respectively. Stopping alcohol
consumption is not sufficient for recovery in many moderate and
severe patients and the use of treatments to reduce liver
inflammation, such as corticosteroids, are limited by
contraindications and have been shown to provide no survival
benefit at 90 days or 1 year. While liver transplantation is
becoming more common for alcoholic liver disease patients,
including for AH patients, the procedure involves a long waiting
period, a burdensome selection process and costs more than
$875,000 on average.
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), epigenetic enzymes
which are elevated and associated with hypermethylation found in
alcohol-associated hepatitis (AH) patients. Larsucosterol is in
clinical development for the potential treatment of AH, 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 development and
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 Statement. This press
release contains forward-looking statements relating to, among
other things, DURECT's relationship with Innocoll, statements about
the potential for larsucosterol (also known as DUR-928) to treat
patients with AH, NASH, multiple acute organ injury, chronic liver
diseases and other diseases, ongoing clinical trials of
larsucosterol, and the potential benefits of Fast Track
Designation. Any statements contained in this press release that
are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "planned," "will," "may,"
"expect," "anticipate," and similar expressions are intended to
identify these forward-looking statements. These forward-looking
statements are based on DURECT's current expectations and
inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
and uncertainties that Innocoll may not launch or commercialize
POSIMIR successfully, if at all, the risk that the clinical trial
of larsucosterol in AH takes longer to conduct than anticipated due
to COVID-19 or other factors, the risk that clinical trials of
larsucosterol, including AHFIRM, do not confirm the results from
earlier clinical or pre-clinical trials, or do not demonstrate the
safety or efficacy or the lifesaving potential of larsucosterol in
a statistically significant manner, the risk that Fast Track
Designation for larsucosterol in AH may not lead to faster FDA
review or an approval, risks related to DURECT's ability to obtain
capital to fund operations and expenses, risks related to market
competition, and other risks described in the "Risk Factors"
section of DURECT's Quarterly Report on Form 10-Q for the period
ended September 30, 2021 filed with
the Securities and Exchange Commission (the "SEC") on November 3, 2021, and in other filings filed from
time to time with the SEC. DURECT does not undertake any obligation
to update forward-looking statements and expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein,
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