CUPERTINO, Calif., Sept. 22, 2020 /PRNewswire/ -- DURECT
Corporation (NASDAQ: DRRX) today announced the study design for the
Phase 2b AHFIRM clinical trial of
DUR-928 in severe alcoholic hepatitis (AH) patients.
AHFIRM is a randomized, double-blind, placebo-controlled,
international, multi-center Phase 2b
study to evaluate the safety and efficacy of DUR-928 in
approximately 300 patients with severe AH. The study will be
comprised of three arms of approximately 100 patients each: (1)
DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard
of care (SOC). SOC may include the use of methylprednisolone, a
corticosteroid, at the discretion of the treating physician.
Patients will receive an intravenous (IV) dose of DUR-928 or
placebo (sterile water) on day 1 and a second IV dose on day 4 if
they are still hospitalized. The primary outcome measure will be
90-day survival rate for patients treated with DUR-928 compared to
those treated with placebo plus SOC. Secondary endpoints
include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in
the intensive care unit. The Company is targeting 40-45 clinical
trial sites in the US and Europe
and anticipates trial initiation in October.
"We are pleased to announce the design and pending initiation of
this important clinical trial," stated James E. Brown, D.V.M., President and CEO of
DURECT. "Following on the very encouraging results from our
Phase 2a AH trial, we believe that the Phase 2b AHFIRM trial will provide a robust evaluation
of the safety and potential life-saving capacity of DUR-928 in
severe AH patients, who desperately need an effective therapy."
About Alcoholic Hepatitis (AH)
AH is an acute form of alcoholic liver disease (ALD) associated
with long-term heavy intake of alcohol, and often occurs after a
recent period of increased alcohol consumption. AH is typically
characterized by recent onset jaundice and hepatic failure.
According to the Agency for Healthcare Research and Quality (AHRQ),
a part of the US Department of Health and Human Services (HHS),
there were over 117,000 hospitalizations for patients with AH in
2016. From a recent publication analyzing the mortality and costs
associated with AH, the cost per patient is estimated at over
$50,000 in the first year. ALD is one
of the leading causes of liver transplants in the U.S., costing
over $800,000 per patient.
About DUR-928
DURECT's lead drug candidate, DUR-928, is an endogenous sulfated
oxysterol and an epigenetic regulator. It represents a new class of
therapeutics with a unique mechanism of action. DUR-928
epigenetically modulates the expression of multiple clusters of
master genes that are involved in many important cell signaling
pathways, through which it stabilizes mitochondria, reduces
lipotoxicity, regulates inflammatory or stress responses, and
promotes cell survival.
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. DUR-928, the company's
lead drug candidate is in clinical development for the potential
treatment of alcoholic hepatitis (AH), COVID-19 patients with acute
liver or kidney injury, and nonalcoholic steatohepatitis (NASH).
DURECT's proprietary drug delivery technologies are designed to
enable new indications and enhanced attributes for small-molecule
and biologic drugs. One late-stage product candidate in this
category is POSIMIR® (bupivacaine extended-release
solution), an investigational locally-acting, non-opioid analgesic
intended to provide up to three days of continuous pain relief
after surgery. For more information about DURECT, please visit
www.durect.com and follow us on Twitter
https://twitter.com/DURECTCorp.
DURECT Forward-Looking Statement
The statements in this press release regarding clinical
development plans for DUR-928, including the potential use of
DUR-928 to treat AH and other acute organ injuries, including in
COVID-19 patients, as well as chronic liver diseases, such as NASH,
and the potential use of POSIMIR to provide pain relief after
surgery 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 risks that the
start of the AHFIRM trial or other trials will be delayed due to
COVID-19 or other factors, that the AHFIRM trial will take longer
than expected and may not replicate results from earlier trials,
that the clinical trial of DUR-928 in COVID-19 patients is delayed
or stopped because of changes to the standard of care, the
availability of alternative therapies, required protocol changes or
lack of available patients, the risk that clinical trials of
DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a
statistically significant manner, the risk that the FDA will not
approve POSIMIR or approve POSIMIR with a limited label, the risk
that additional time and resources may be required for development,
testing and regulatory approval of DUR-928 or the Company's other
product candidates, potential adverse effects arising from the
testing or use of our drug candidates, our potential failure to
maintain our collaborative agreements with third parties and risks
related to our ability to obtain capital to fund operations and
expenses. Further information regarding these and other risks is
included in DURECT's Form 10-Q filed on August 4, 2020 under the heading "Risk
Factors."
NOTE: POSIMIR® and SABER® are trademarks
of DURECT Corporation. Other referenced trademarks belong to
their respective owners. DUR-928 and POSIMIR are
investigational drug candidates under development and have 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