ContraVir Pharmaceuticals Announces Acceptance of Clinical Trial Application in the United Kingdom
September 06 2017 - 6:00AM
ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical
company focused on the development and commercialization of
targeted antiviral therapies, announced today that the Clinical
Trial Application (CTA) for the formulation optimization clinical
program for TXL™ has been approved in the United Kingdom by the
Medicines & Healthcare Products Regulatory Agency (MHRA).
Earlier this year, ContraVir announced that it had completed a
Phase 1, multiple dose study in healthy subjects and a Phase 2a, 28
day study which was a head-to-head comparison of TXL™ to Viread® in
HBV-infected subjects. Having successfully achieved
proof-of-concept with the first generation formulation of TXL™,
ContraVir is developing a second-generation formulation of TXL™ to
further optimize the pharmacological characteristics of its novel,
liver-targeted tenofovir prodrug, Data from this program will drive
the continued clinical development of TXL™, and support the goals
of enhanced efficacy at lower doses, potentially delivering greater
antiviral potency, while maintaining the low concentrations of
circulating tenofovir in the blood necessary to minimize the risks
of bone and kidney toxicity seen with Viread®.
ContraVir expects to dose its first patient in the UK before the
end of this month. “We look forward to reporting on our progress,
as our team is committed to establishing TXL™ as a potent and safe
potential backbone therapy for a functional cure,” said James
Sapirstein, Chief Executive Officer at ContraVir. “This is yet
another great milestone achieved, as key European approval will
permit accelerated optimization of our new formulation and further
differentiation of TXL™ in the clinic.”
About TXL™
Tenofovir exalidex (TXL™) is a highly potent prodrug of the
antiviral tenofovir. Tenofovir is the active component of
both Vemlidy® (tenofovir alafenamide) and Viread® (tenofovir
disoproxil fumarate).TXL™’s novel liver-targeting prodrug structure
results in decreased systemic circulating levels of tenofovir,
thereby reducing the potential for renal and bone side effects.
ContraVir has completed a Phase 2 trial of TXL™, in which
HBV-infected subjects were administered doses up to 100 mg for 28
days and is now optimizing the formulation of TXL™ to further
enhance drug bioavailability. To date, TXL™ has achieved clinical
proof of concept for antiviral activity and displayed an excellent
safety, tolerability, and pharmacokinetic profile. Based on the
agent’s best-in-class potential, ContraVir believes TXL™ 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. TXL™
currently in Phase 2, is designed to deliver high intrahepatic
concentrations of TFV, while minimizing off-target side-effects
caused by high levels of circulating TFV. CRV431, the other
anti-HBV compound, is a next-generation cyclophilin inhibitor with
a unique structure that increases its potency and selective index
against HBV. ContraVir is also developing Valnivudine™, an orally
available nucleoside analogue prodrug; Valnivudine™ is currently in
Phase 3 for the treatment of herpes zoster. In addition to
direct antiviral activity, Phase 2 data suggest that Valnivudine™
has the potential to reduce the incidence of debilitating
shingles-associated pain known as post-herpetic neuralgia
(PHN). 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
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