EDISON, N.J., Oct. 17, 2016 /PRNewswire/ -- ContraVir
Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company
focused on the development and commercialization of targeted
antiviral therapies, announced today that following a positive
recommendation from an independent Data Safety Monitoring Board
(DSMB), the company has begun enrolling the next dosing group in
its head-to-head Phase 2a dose-escalation study comparing the
safety and efficacy of ContraVir's CMX157 to tenofovir disoproxil
fumarate (TDF, marketed by Gilead Sciences as Viread®)
in patients with chronic hepatitis B (HBV). ContraVir expects to
complete the remaining two escalation cohorts and report top-line
results by year-end 2016.
The DSMB conducted an independent review of the safety,
tolerability and pharmacokinetic profile of CMX157 from the
completed 5 mg, 10 mg and 25 mg dosing groups of ContraVir's
ongoing, 28-day, Phase 2a study in HBV-infected patients.
Based on CMX157's favorable safety and tolerability in this study
as well as in a completed Phase 1b study in healthy volunteers,
which dosed up to 100 mg of CMX157 per day, the DSMB approved
proceeding to a higher dose in the ongoing Phase 2a dose escalation
trial per study protocol.
"Coupled with our recent demonstration of clinical proof of
concept for CMX157 in HBV patients, the DSMB's confirmation of
CMX157's safety profile continues to build the case for this
drug's potential as a cornerstone for combination therapy to cure
HBV," said James Sapirstein, CEO of
ContraVir. "We look forward to reporting final Phase 2a data
by year end, and continue to believe that CMX157 has the ideal
attributes needed for use as a component of a future combination
drug strategy where drug-drug interactions put high demands on
safety."
ContraVir recently announced positive interim data demonstrating
strong antiviral activity and favorable safety and pharmacokinetics
for CMX157. Notably, a 25 mg dose of CMX157 achieved
comparable HBV viral load reduction to the standard 300 mg dose of
Viread®, but with significantly reduced systemic levels
of active tenofovir. Results from the completed Phase 1b and
ongoing Phase 2a clinical trials suggest that CMX157 is a highly
potent HBV antiviral that may mitigate the risk of kidney and bone
toxicities that are associated with Viread®.
CMX157 Phase 2 Clinical Trial Design
The Phase 2a
multiple ascending dose clinical trial, which is designed to enroll
60 treatment-naïve patients with chronic HBV infection, compares
CMX157 to tenofovir disoproxil fumarate (TDF, Gilead's
Viread®). The sequential dose escalation format
consists of 10 patients per cohort receiving four weeks of a
once-daily dose of 5, 10, 25, 50 and 100 mg, respectively, of
CMX157, plus two patients per cohort receiving 300 mg of TDF, the
standard therapeutic dose of Viread®.
About CMX157
CMX157 is a highly potent analog of the
successful antiviral drug tenofovir. Its novel
liver-targeting structure results in decreased circulating levels
of tenofovir, lowering systemic exposure and thereby reducing the
potential for renal side effects. CMX157 previously completed
a Phase 1b dose escalation clinical study conducted in healthy
volunteers, in which participants were treated at doses up to 100
mg per day for 14 days, displaying an excellent safety,
tolerability, and drug distribution profile. Based on
CMX157's best-in-class potential, ContraVir believes CMX157 can
become the cornerstone of a curative combination therapy for
hepatitis B.
About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the development
and commercialization of targeted antiviral therapies with a
specific focus on developing a potentially curative therapy for
hepatitis B virus (HBV). The Company is developing two novel
anti-HBV compounds with complementary mechanisms of action: CMX157,
a highly potent analog of the successful antiviral drug tenofovir
currently in a Phase 2a clinical trial in HBV patients; and CRV431,
a next generation cyclophilin inhibitor with a unique structure
that increases its potency and selective index against HBV.
ContraVir is also developing FV-100, an orally available nucleoside
analogue prodrug for the treatment of herpes zoster, or shingles,
in a Phase 3 clinical trial. In addition to direct antiviral
activity, FV-100 previously demonstrated the potential to reduce
the incidence of debilitating shingles-associated pain known as
post-herpetic neuralgia (PHN) in a Phase 2 clinical study. For
more information visit www.contravir.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimated" and "intend," among others. These forward-looking
statements are based on ContraVir's current expectations and actual
results could differ materially. There are a number of factors that
could cause actual events to differ materially from those indicated
by such forward-looking statements. These factors include, but are
not limited to, substantial competition; our ability to continue as
a going concern; our need for additional financing; uncertainties
of patent protection and litigation; uncertainties with respect to
lengthy and expensive clinical trials, that results of earlier
studies and trials may not be predictive of future trial results;
uncertainties of government or third party payer reimbursement;
limited sales and marketing efforts and dependence upon third
parties; and risks related to failure to obtain FDA clearances or
approvals and noncompliance with FDA regulations. As with any drug
candidates under development, there are significant risks in the
development, regulatory approval, and commercialization of new
products. There are no guarantees that future clinical trials
discussed in this press release will be completed or successful, or
that any product will receive regulatory approval for any
indication or prove to be commercially successful. ContraVir does
not undertake an obligation to update or revise any forward-looking
statement. Investors should read the risk factors set forth in
ContraVir's Form 10-K for the year ended June 30, 2016, and other periodic reports filed
with the Securities and Exchange Commission.
For further information, please contact:
Sharen Pyatetskaya
Director of Investor Relations
sp@contravir.com; (732) 902-4028
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D. (investors)
jdrumm@tiberend.com; (212) 375-2664
Claire LaCagnina (media)
clacagnina@tiberend.com; (212) 375-2686
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SOURCE ContraVir Pharmaceuticals, Inc.