CUPERTINO, Calif., Nov. 19, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced it has amended its
ongoing Phase 2a clinical trial of intravenously administered
DUR-928 in patients with alcoholic hepatitis (AH) to accelerate the
initiation of dosing of severe AH patents. The Company
recently completed dosing for the low-dose 30 mg cohort (n=4) of
Part A (moderate AH patients), and with this amendment in
place, can now begin enrolling Part B (severe AH patients),
starting with the low dose, while it simultaneously continues
enrolling Part A at the next higher dose (90 mg). DUR-928, the
lead investigational product in the Company's Epigenetic Regulator
Program, is an endogenous, first-in-class small molecule, which may
have broad applicability in diseases such as nonalcoholic
steatohepatitis (NASH) and other disorders of the liver such as
Primary Sclerosing Cholangitis (PSC), in acute organ injuries such
as acute liver and kidney injury, and in inflammatory skin
disorders such as psoriasis and atopic dermatitis.
"This amendment will enable dosing in severe AH patients in
parallel to the moderate patients, and we expect it to accelerate
the overall timeline for the trial," said James E. Brown,
President and CEO of DURECT. "Over the course of the
trial, the clinical sites have encountered many severe AH patients
who may have qualified for Part B but were deemed screen failures
due to their MELD scores being too high to participate in Part
A."
The Phase 2a trial is an open label, dose escalation,
multi-center U.S. study, originally designed to be conducted in two
sequential parts. Part A includes patients with moderate AH (as
determined by the Model of End-Stage Liver Disease (MELD) scores, a
common scoring system to assess the severity and prognosis of AH
patients), and Part B includes patients with severe AH. Three dose
levels of DUR-928 (30, 90 and 150 mg) are planned for testing in
Part A. Dose escalation is permitted following review of safety and
pharmacokinetic (PK) results of the prior dose level by a Dose
Escalation Committee (DEC). The target number of patients for the
study is 4-6 per dose group. The objectives of this study include
safety, PK and pharmacodynamic (PD) signals, as well as measuring
the effect of DUR-928 on liver biochemistry and
biomarkers. Additional information on the trial design,
including eligibility criteria and site locations, can be found
at www.clinicaltrials.gov using the NCT Identifier
NCT03432260.
About Alcoholic Hepatitis
AH is a syndrome of progressive inflammatory liver injury
associated with long-term heavy intake of alcohol, and encompasses
a spectrum that ranges from mild injury to severe, life threatening
liver damage. The prevalence of AH is estimated to occur in 10-35%
of heavy drinkers. According to an article in the Journal of
Clinical Gastroenterology (2015 July; 49(6): 506-511), there
were over 320,000 hospitalizations related to alcoholic hepatitis
in 2010, resulting in hospitalization costs of
nearly $50,000 per patient.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 2 development, is the lead candidate
in DURECT's Epigenetic Regulator Program. An endogenous,
orally bioavailable small molecule, DUR-928 has been shown in
preclinical studies to play an important regulatory role in lipid
homeostasis, inflammation, and cell survival. Human
applications may include acute organ injury such as Alcoholic
Hepatitis (AH), hepatic and renal diseases such as nonalcoholic
steatohepatitis (NASH) and Primary Sclerosing Cholangitis (PSC),
and inflammatory skin conditions such as psoriasis and atopic
dermatitis. DURECT's advanced oral and injectable
delivery technologies are designed to enable new indications and
enhanced attributes for small-molecule and biologic drugs.
Late stage product candidates in this category include
POSIMIR® (bupivacaine extended release solution),
an investigational locally-acting, non-opioid analgesic intended to
provide up to 3 days of continuous pain relief after surgery, and
ORADUR®-Methylphenidate ER Capsules, approved
in Taiwan as Methydur Sustained Release Capsules, where
it is indicated for the treatment of attention deficit
hyperactivity disorder (ADHD). In addition, for the
assignment of certain patent rights related to its drug delivery
technology, DURECT will receive single digit sales-based
earn-out payments from U.S. net sales
of PERSERIS™ (risperidone), which was approved
by FDA in July 2018 for the treatment
of schizophrenia in adults and is owned and marketed by Indivior
PLC. For more information, please
visit www.durect.com.
NOTE: ORADUR®, POSIMIR® and
SABER® are trademarks of DURECT
Corporation. Other referenced trademarks belong to their respective
owners. DUR-928 and POSIMIR are drug candidates under development
and have not been approved for commercialization by the U.S.
Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding clinical
development plans for DUR-928, including potential acceleration of
the Phase 2a trial in AH, potential future payments
from Indivior, and the potential benefits and uses of our drug
candidates, including the potential use of DUR-928 to treat PSC,
AH, other disorders of the liver, kidney diseases, acute organ
injuries, psoriasis, atopic dermatitis or other inflammatory
conditions 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
clinical trials of DUR-928 are not started when anticipated, take
longer to conduct than anticipated, or do not demonstrate the
safety or efficacy of DUR-928 in a statistically significant
manner, the risk that Indivior will not launch PERSERIS
or that it will obtain marketplace acceptance, the risk that prior
clinical trials will not be confirmed in subsequent trials, the
potential failure of clinical trials to meet their intended
endpoints, the risk that additional time and resources that may be
required for development, testing and regulatory approval of
DUR-928, potential adverse effects arising from the testing or use
of our drug candidates, 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 November 8,
2018 under the heading "Risk Factors."
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SOURCE DURECT Corporation