CUPERTINO, Calif., Oct. 7, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that it has
completed enrollment in its Phase 2a clinical trial of topical
DUR-928 in patients with mild to moderate plaque psoriasis. The
company also announced that it has now enrolled 30 of the planned
60 patients in its ongoing Phase 1b
trial with oral DUR-928 in patients with non-alcoholic
steatohepatitis (NASH).
"We are pleased that on the heels of completing the alcoholic
hepatitis trial on schedule and announcing positive results, we
have also achieved important enrollment milestones in our ongoing
psoriasis and NASH trials," said James E.
Brown, President and CEO of DURECT. "With these two trials
progressing as planned, we are approaching important data readouts
for DUR-928 in these difficult to treat conditions."
The company expects to announce top line data from the psoriasis
trial by the end of this year. The NASH trial is on schedule to be
completed in the first half of 2020 and the company plans to
announce top line study results following completion of the
trial.
About the DUR-928 Psoriasis Phase 2a Trial
The trial is a Phase 2a, randomized, double-blind,
vehicle-controlled, multi-center, proof-of-concept study in which
DUR-928 is applied topically once-daily for 28 days with a 28-day
follow-up period in patients with mild to moderate plaque
psoriasis. The trial is being conducted in the U.S. The plan was to
enroll at least 20 patients to have 15 evaluable patients. At the
time of this announcement, more than 20 patients have been
enrolled. Each patient serves as their own control, applying
DUR-928 to the plaque on one arm and the vehicle (placebo) to a
similar plaque on the other arm. After the treatment period,
patients will be followed for an additional four weeks. The primary
efficacy endpoint is change in local psoriasis scores from baseline
in the DUR-928-treated plaques compared to the vehicle-treated
plaques.
About the DUR-928 NASH Phase 1b
Trial
In March 2019 we began enrolling
patients in a Phase 1b randomized and
open-label clinical study being conducted at multiple centers in
the U.S. to evaluate safety, pharmacokinetics (PK) and signals of
biological activity of DUR-928 in NASH patients with stage 1-3
fibrosis. Patients take oral DUR-928, at one of three doses (50 mg
QD, 150 mg QD and 300 mg BID), daily for 28 consecutive days and
are then followed for 28 days. The plan is to enroll 20 patients
per dose group (with 15 evaluable) for a total of approximately 60
patients in the trial. Key endpoints include safety, PK, and
signals of biological activities, including clinical chemistry and
biomarkers as well as liver fat content by imaging.
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) and acute
kidney injury (AKI), chronic hepatic diseases such as nonalcoholic
steatohepatitis (NASH), 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. Key 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, a
long-acting injectable SABER-based HIV product being developed with
Gilead, 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, DURECT receives single
digit sales-based earn-out payments from U.S. net sales of
Indivior's PERSERIS™ (risperidone) drug for
schizophrenia, which was commercially launched in February 2019. For more information about DURECT,
please visit www.durect.com.
NOTE: POSIMIR®, SABER® and
ORADUR™ 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 plans, enrollment
rates, timing to obtain data and complete data analyses from the
Phase 2a trial of DUR-928 in patients with psoriasis and the Phase
1b trial of DUR-928 in patients with
NASH are forward looking statements, which are subject to risks and
uncertainties. These risks and uncertainties include, but are not
limited to, the risk of delays in enrollment, or that the trials
will not meet their respective endpoints or reveal adverse safety
information. This press release also includes additional
forward-looking statements, including regarding the potential use
of DUR-928 to treat AH, AKI, chronic hepatic diseases such as NASH,
and inflammatory skin disorders such as psoriasis and atopic
dermatitis, as well as statements regarding the use of POSIMIR to
treat post-surgical pain, the use of Methydur to treat ADHD, and
potential earn-out payments from U.S. sales of PERSERIS. These
forward-looking statements involve 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 risk of potential adverse
effects arising from the testing or use of DUR-928, the risk that
results from earlier trials may not be replicated in future
clinical trials, including in trials with larger numbers of
patients, the risk that the FDA may not approve the POSIMIR NDA,
the risk that PERSERIS and Methydur will not be successfully
commercialized, our ability to avoid infringing patents held by
other parties and secure and defend patents of our own patents, and
our ability to manage and obtain capital to fund our operations and
expenses. Further information regarding these and other risks is
included in DURECT's Form 10-Q filed with the Securities and
Exchange Commission on August 2, 2019
under the heading "Risk Factors."
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SOURCE DURECT Corporation