CUPERTINO, Calif., March 21, 2019 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced it has commenced patient dosing in a
Phase 2a proof-of-concept trial with topical DUR-928 in patients
with mild to moderate plaque psoriasis. 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 chronic hepatic diseases such as
nonalcoholic steatohepatitis (NASH), acute organ injuries such as
alcoholic hepatitis (AH) and acute kidney injury (AKI), and in
inflammatory skin disorders such as psoriasis and atopic
dermatitis.
"As topical agents continue to be the mainstay of treatment for
patients suffering from mild to moderate plaque psoriasis,
especially localized plaque psoriasis, it is important to
investigate a topical agent with a novel mechanism of action,"
stated Dr. Howard Maibach, Professor
of Dermatology at the University of
California San Francisco. "Should the results be
positive, DUR-928 should be studied in additional inflammatory skin
diseases."
"Commencing patient dosing in this proof-of-concept psoriasis
trial is an important milestone in line with our focus for DUR-928
in 2019, which is to produce data with the potential to create
significant commercial and partnering value," said James E. Brown, President and CEO of DURECT.
In this Phase 2a, randomized, double-blind, vehicle-controlled
proof-of-concept clinical trial, DUR-928 will be applied topically
once-daily for four weeks in patients with mild to moderate plaque
psoriasis. The trial is being conducted at multiple clinical sites
in the U.S. Twenty patients are planned to be enrolled to
obtain approximately 15 evaluable patients. Patients will serve as
their own controls, applying DUR-928 to the plaque on one arm and
the vehicle 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 will be change in local
psoriasis scores from baseline in the DUR-928-treated plaques
compared to that in the vehicle-treated plaques. We expect to
announce top line data from this study in the second half of 2019.
Additional information on the trial design, including eligibility
criteria and site locations, can be found at
https://clinicaltrials.gov/ using the NCT Identifier NCT
03837743.
DURECT previously conducted an exploratory Phase 1b trial in psoriasis patients (9 evaluable
patients) in Australia. The trial was randomized,
double-blinded, placebo and self-controlled, using a micro-plaque
assay with intralesional injections of DUR-928. The results
were encouraging and warranted advancing into the current
proof-of-concept trial with topically applied DUR-928.
Key Opinion Leader (KOL) Call
On Friday, March 29, 2019 at
11:00am EST/8:00am PST, DURECT will be hosting a KOL call
providing an overview of psoriasis and the treatment landscape for
topical medications in psoriasis. The call will feature a
presentation by KOL Howard Maibach, MD, Professor of Dermatology
and practicing dermatologist at the University
of California San Francisco (UCSF). DURECT will also provide
an overview of the Company's development program for DUR-928 and
Dr. Maibach will be available to answer questions after the
presentations.
Dial-In &
Webcast Information
|
|
Friday, March
29 @ 11am Eastern Time / 8am Pacific Time
|
|
Domestic:
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888-254-3590
|
International:
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323-994-2093
|
Conference
ID:
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3271109
|
Webcast
w/Slides:
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http://public.viavid.com/index.php?id=133666
|
About Psoriasis
Psoriasis is an inflammatory skin disease and an immune-mediated
condition that causes the body to make new skin cells in days
rather than weeks. In the United
States, there are about 150,000 new cases of psoriasis every
year and it affects an estimated 7.5 million Americans.
According to the International Federation of Psoriasis Associations
(IFPA), nearly 3% of the world's population has some form of
psoriasis or about 125 million people. Psoriasis causes itchiness
and irritation and may be painful. There is no cure for psoriasis,
but treatment can ease symptoms. Approximately 80%
of patients with psoriasis have
localized disease, which can be
treated with topical therapies. As such,
topical agents remain the mainstay of psoriasis treatment.
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. 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, DURECT
receives single digit sales-based earn-out payments from U.S. net
sales of Indivior's PERSERIS™ (risperidone) drug for
schizophrenia, which was approved in July
2018 and commercially launched in February 2019. For
more information, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the planned Phase
2a trial of DUR-928 in mild to moderate plaque psoriasis, the
potential of DUR-928 to show positive signals of biological
activity in such trial, the potential use of DUR-928 to treat
chronic hepatic diseases such as NASH, acute organ injuries such as
alcoholic hepatitis (AH) and acute kidney injury (AKI), and in
inflammatory skin disorders such as psoriasis and atopic
dermatitis, the use of POSIMIR to treat post-surgical pain, the use
of Indivior's PERSERIS™ to treat schizophrenia, as well
as the potential commercial sales of Indivior's PERSERIS 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 risk of delays in the
commencement and enrollment of the planned clinical trial of
DUR-928 in mild to moderate plaque psoriasis, potential adverse
effects arising from the testing or use of DUR-928, the risk that
the FDA may not approve the POSIMIR NDA, the risk that PERSERIS
will not have a successful launch, 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-K on March 8, 2019 under the heading "Risk
Factors."
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. Full prescribing
information for PERSERIS, including BOXED WARNING, and Medication
Guide can be found at www.perseris.com.
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SOURCE DURECT Corporation