CUPERTINO, Calif., June 18, 2019 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced that it has completed dosing the 90
mg cohort of severe AH patients in its ongoing DUR-928 Phase 2a
clinical trial, and that after reviewing safety and pharmacokinetic
(PK) data from the completed cohorts, the Dose Escalation Committee
(DEC) has approved commencement of dosing at the 150 mg level in
severe AH patients. Enrollment for moderate AH patients to be dosed
at the 90 mg level will continue in parallel to enrollment for
severe AH patients to be dosed at the 150 mg level.
"Preliminary data from the completed cohort of severe AH
patients dosed at 90 mg are consistent with the preliminary data
from 30 mg and 90 mg patients we reported last month," said
James E. Brown, President and CEO of
DURECT. "We are excited to be moving into the final dosing cohort
for patients with severe AH and look forward to completing the
trial and reporting the data at a future medical conference."
About the Ongoing DUR-928 Alcoholic Hepatitis Phase 2a
Trial
DURECT is conducting a Phase 2a clinical trial with
intravenously administered DUR-928 in patients with AH. This
is an open label, dose escalation (30, 90 and 150 mg), multi-center
U.S. study that is enrolling patients with moderate and severe
AH. Dose escalation may occur following review of safety and
PK results of the prior dose level by a DEC. The target number of
patients for the study is 4 moderate and 4 severe patients per dose
group. The objectives include assessment of safety, PK and
pharmacodynamic (PD) signals, including liver chemistry and
biomarkers.
As reported on May 7 and 8, 2019
through a press release and key opinion leader conference call,
preliminary clinical data from the first 10 AH patients dosed with
DUR-928 demonstrated significant reductions from baseline of serum
bilirubin levels and MELD scores, and significantly lower
Lille scores compared to
historical controls. In addition, DUR-928 was well tolerated and PK
parameters were not affected by the severity of the disease.
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 commercially launched in February
2019. For more information about DURECT, please visit
www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding plans,
preliminary data and potential results from the ongoing Phase 2a
trial of DUR-928 in patients with AH are forward looking
statements, which are subject to risks and uncertainties.
These risks and uncertainties include the risk that preliminary
results may not predict the results for the full trial or for the
outcomes of the patients whose data is reported. This press
release also includes additional forward-looking statements,
including regarding clinical trial plans for DUR-928, 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, that the remainder of the Phase 2a
clinical trial of DUR-928 in AH patients does not replicate the
preliminary results reported here, the risk of delays in the
enrollment of the ongoing clinical trials of DUR-928 in AH, NASH
and 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 and Methydur will not have
successful commercial launches, 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 May 7,
2019 under the heading "Risk Factors."
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SOURCE DURECT Corporation