CUPERTINO, Calif., Jan. 2, 2020 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced the results from
its Phase 2a clinical trial of DUR-928 in patients with mild to
moderate plaque psoriasis. Twenty-two patients completed the study,
applying DUR-928 topically to the plaque on one arm and the vehicle
(placebo) to a similar plaque on the other arm daily for 28
days.
DUR-928 did not demonstrate a benefit over vehicle (placebo)
based on Investigator's Global Assessment (IGA), which was the
scoring system for the primary analysis, or in any of the secondary
analyses. Daily topical application of DUR-928 was well tolerated
with no meaningful differences in adverse events between the
treatment and vehicle (placebo) groups. There were no AEs
attributed to the study drug.
"Based on the top-line data, we do not plan to continue
development of topical DUR-928 in psoriasis," said James E. Brown, President and CEO of DURECT.
"With the recently announced positive results from our Phase 2a
alcoholic hepatitis trial, our focus moving forward with DUR-928,
will be on completing the NASH trial in the first half of this year
and initiating the Phase 2b AH trial
in the middle of the year."
About the DUR-928 Psoriasis Phase 2a Trial
The trial was a Phase 2a, randomized, double-blind,
vehicle-controlled, multi-center, proof-of-concept study in which
DUR-928 was applied topically once-daily for 28 days with a 28-day
follow-up period in patients with mild to moderate plaque
psoriasis. The trial was conducted in the U.S. Each patient
served 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 were followed for an
additional four weeks.
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 AH and acute kidney injury (AKI)
and chronic hepatic diseases such as NASH. 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, and a long-acting injectable SABER-based HIV
investigational product being developed with Gilead. For more
information about DURECT, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential
benefits and uses of DUR-928 to treat AH and about other potential
uses of DUR-928 to treat NASH, AKI and other diseases, the
potential use of POSIMIR to treat post-operative pain, and the
potential development of a long-acting injectable SABER-based HIV
product with Gilead 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 clinical trials or adverse safety events from
patients administered with DUR-928, the risk that the ongoing
clinical trial of DUR-928 in NASH does not successfully achieve its
endpoints, the risk that placebo controlled studies of DUR-928
required for regulatory approval will not replicate results from
open label clinical trials or trials with small numbers of patients
or historical controls, the risks that the long-acting injectable
SABER-based HIV investigational product being developed with Gilead
will not succeed or that Gilead will abandon this program, the risk
that the FDA Advisory Committee will not recommend approval of
POSIMIR or that the FDA will not approve POSIMIR, and the risk of
delays and costs due to additional work or other requirements
imposed by regulatory agencies for continued development, approval
or sale of any of our product candidates. Further information
regarding these and other risks related to DURECT is included in
DURECT's Form 10-Q filed on November 5,
2019 under the heading "Risk Factors" and in subsequent
reports that we file with the Securities and Exchange
Commission.
NOTE: 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.
View original
content:http://www.prnewswire.com/news-releases/durect-corporation-announces-top-line-results-from-phase-2a-clinical-trial-in-patients-with-psoriasis-300980269.html
SOURCE DURECT Corporation