CUPERTINO, Calif., Sept. 23, 2020 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced it has dosed the first patient in
its randomized, double-blind, placebo-controlled, multi-center
Phase 2 study to evaluate the safety and efficacy of DUR-928 in
hospitalized COVID-19 patients with acute liver or kidney injury.
The primary efficacy endpoint is a composite of survival and being
free of acute organ failure at Day 28. The company plans to enroll
approximately 80 patients in multiple study sites across the
U.S.
"We are excited to have begun dosing DUR-928 in this population
of hospitalized COVID-19 patients with the additional complications
of acute liver or kidney injury. These patients are at risk of
multi-organ failure and death, similar to hospitalized patients
with AH," stated James E. Brown,
D.V.M., President and CEO of DURECT. "Based on the positive
clinical results of DUR-928 in hospitalized AH patients from our
Phase 2a trial and our preclinical data in multi-organ failure
models, we believe that DUR-928, in combination with standard of
care, has the potential to help these COVID-19 patients."
About the Phase 2 Trial
This Phase 2, randomized, double-blind, placebo-controlled,
multi-center study is designed to evaluate safety and efficacy of
DUR-928 in COVID-19 patients with acute liver or kidney injury. A
total of approximately 80 patients are planned to be enrolled into
two study treatment groups in a 3:1 (DUR-928: placebo) ratio.
Patients will receive a dose of 150 mg of DUR-928 or placebo by
intravenous infusion on day 1 and day 4 in combination with
standard of care therapy, which will be determined by the principal
investigator (PI) at each clinical trial site. The primary efficacy
endpoint is a composite of survival and being free of acute organ
failure (free of mechanical ventilation, free of liver failure
events and free of renal replacement therapy) at day 28. Patients
will be followed for 60 days. Should any drug product be determined
by the FDA to be safe and effective for the treatment of COVID-19
while the trial is ongoing, such treatments may be offered, at each
PI's discretion, to any remaining and future patients in this
trial. For more information, refer to
ClinicalTrials.gov Identifier: NCT04447404
About COVID-19
COVID-19 is an infectious disease caused by severe acute
respiratory syndrome coronavirus (SARS-COV-2). The rapid spread of
the disease has resulted in a pandemic with millions of confirmed
cases and hundreds of thousands of deaths worldwide. While most
cases result in mild symptoms, including fever, cough and shortness
of breath, some rapidly progress into acute respiratory distress
syndrome (ARDS), multi-organ failure, and death. Many of
these patients experience a rapid elevation of
inflammation-inducing signaling molecules (cytokine storm) that
trigger acute injuries in multiple organs including the liver and
the kidney. Organ injury may also occur in hospitalized COVID-19
patients as the result of other complications of the viral
infection. In a study of 1,059 adult cases of confirmed
hospitalized COVID-19, 62% of patients presented with at least one
elevated liver enzyme. In another study, 36.6% of 5,449 patients
admitted with COVID-19 had or developed acute kidney injury
(AKI).
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 COVID-19 patients with liver or kidney injury, the
potential use of DUR-928 to treat acute organ injuries, such as AH,
and 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 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 future clinical trials of DUR-928 are not started when
anticipated, take longer to conduct than anticipated, do not
confirm the results from earlier clinical or pre-clinical trials,
or 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