CUPERTINO, Calif., Jan. 7, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) has refined and focused its clinical
development strategy for DUR-928, the lead product candidate in its
Epigenetic Regulator Program, to prioritize indications with unmet
medical needs where we expect to be able to generate near-term data
with the potential to create significant commercial and partnering
value. The new DUR-928 clinical development strategy is:
1. Accelerate DUR-928 clinical trial in non-alcoholic
steatohepatitis (NASH) patients.
- DURECT previously announced that it would be initiating a new
clinical trial of orally-administered DUR-928 in NASH patients in
the first half of 2019, and is now updating that guidance to
indicate that the Company expects to begin enrolling patients in Q1
2019.
- This will be an open-label, Phase 1b study conducted in the U.S. to evaluate
safety, pharmacokinetics and signals of biological activity of
DUR-928 in patients with NASH. Patients will be administered
DUR-928 orally for 28 consecutive days. Further details on the
trial design will be provided later in Q1 2019.
- DURECT expects to announce initial data in the second half of
2019.
2. Complete the Phase 2a proof-of-concept trial with
topical DUR-928 in patients with mild to moderate plaque psoriasis
as planned. The Company reiterates its prior guidance that
the psoriasis trial is on track to begin dosing this quarter with
top line data expected in the second half of 2019.
3. Continue and then transition the ongoing DUR-928
alcoholic hepatitis (AH) Phase 2a trial to Dr. Craig McClain at the University of Louisville.
- Since the Company's announcement of the initiation of dosing in
Part B (severe AH patients) in November
2018, two severe AH patients have been treated at the 30 mg
I.V. dose of DUR-928.
- Upon completing the 30 mg dose group in Part B, we plan to
transition the study to Dr. McClain, who was recently awarded an
NIH grant to study DUR-928 in AH patients. After the transition,
the trial will be funded via grants and conducted by Dr.
McClain.
4. Discontinue the primary sclerosing colangitis (PSC)
trial. Given that the Company's efforts have not resulted in an
increase in the inherently slow enrollment rates commonly seen for
this indication, the Company has decided to discontinue its PSC
study in order to focus more of its resources on NASH and
psoriasis.
"Our revised development strategy for DUR-928 will allow our
team to focus on the indications that could provide value-creating,
near-term clinical data and help us formulate a plan to advance
DUR-928 into late stage clinical development," stated James E. Brown, D.V.M., President and CEO of
DURECT. "Showing positive signals of biological activity
after 28 days in NASH patients could be particularly valuable in
demonstrating the potential of DUR-928 in this important disease,
while obtaining positive proof-of-concept data in psoriasis could
lead to a partnership for DUR-928 in the dermatology space."
Update on Selected Other Programs:
POSIMIR® (bupivacaine extended-release
solution)
Sandoz AG provided notice that it is returning to DURECT all of
its U.S. development and commercialization rights to
POSIMIR® (bupivacaine extended release solution)
post-operative pain relief depot. The parties are in dispute
with regard to Sandoz's obligation to pay a termination fee to
DURECT. DURECT has initiated a formal dispute resolution
process related to the termination fee.
"We understand their decision to focus resources on other
programs as their new US leadership continues to implement its
strategy," stated James Brown,
President and CEO of DURECT. "We maintain our belief that
there is a need for additional non-opioid products in the
post-operative pain setting and will continue to evaluate and
consider potential next steps for POSIMIR."
POSIMIR is the Company's investigational post-operative pain
relief depot that utilizes the Company's patented SABER technology
and is designed to deliver bupivacaine to provide up to 3 days of
pain relief after surgery.
Indivior (LON: INDV) Agreement and
PERSERIS™
Indivior PLC stated on December 18,
2018 that it is moving ahead with the launch of PERSERIS in
the U.S. with a sales force consisting of approximately 50
representatives. While PERSERIS has been available in the U.S.
since November 19, 2018, Indivior
stated that the commercial launch is scheduled to take place in
February 2019. Indivior stated that
its PERSERIS team is currently engaged in creating payor access,
growing prescriber awareness and interest, as well as establishing
its INSUPPORT patient hub. Indivior also affirmed that it
remained confident in its peak net revenue goal for PERSERIS of
$200 to $300
million. Under the terms of the agreement with
Indivior, DURECT will receive quarterly earn-out payments that are
based on a single digit percentage of U.S. net sales of PERSERIS
into 2026.
"We look forward to the expected PERSERIS launch in February by
Indivior, and other potential catalysts in 2019 from our drug
delivery programs," stated James
Brown, President and CEO of DURECT.
Conference Call Information
A live audio webcast of a conference call to discuss this
corporate update will be broadcast live over the internet at
8:00 a.m. Eastern Time on
January 7 and will be available by
accessing DURECT's homepage at www.durect.com and clicking
"Investor Relations." If you are unable to participate in the live
webcast, the call will be archived on DURECT's website under Audio
Archive in the "Investor Relations" section.
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 chronic liver diseases such as nonalcoholic steatohepatitis
(NASH), acute organ injury such as Alcoholic Hepatitis (AH) and
acute kidney injury (AKI), 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 will receive
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. For more
information, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding clinical trial
plans for DUR-928, including plans to begin patient enrollment of a
new clinical trial of orally-administered DUR-928 in NASH patients
in Q1 2019 and the potential to show positive signals of biological
activity in such trial, plans to obtain and announce positive
top-line proof of concept data for the planned clinical trial of
DUR-928 in psoriasis in the second half of 2019, the potential to
receive a termination fee from Sandoz related to POSIMIR and the
potential commercial sales of Indivior's PERSERIS to treat
schizophrenia, including the timing of U.S. launch and amount of
potential sales amounts 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 planned clinical
trials, potential adverse effects arising from the testing or use
of DUR-928, potential adverse outcomes in the dispute resolution
process with Sandoz, 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 on November 8, 2018 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.
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SOURCE DURECT Corporation