Data Enhances Understanding of ContraVir’s Complementary Anti-HBV Compounds Tenofovir Exalidex (TXL™) and CRV431
April 22 2017 - 9:44AM
ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical
company focused on the development and commercialization of
targeted antiviral therapies, today presented data demonstrating
the synergistic antiviral activity from the combination of its two
investigational drugs for the treatment of hepatitis B viral (HBV)
infection, tenofovir exalidex (TXL™, formerly CMX157) a nucleotide
reverse transcriptase inhibitor and CRV431, a cyclophilin
inhibitor. In addition, the mode of action (MOA) of CRV431 was
further defined.
The data were presented today in separate poster presentations
at The International Liver Congress® 2017, the annual meeting of
the European Association for the Study of the Liver (EASL) in
Amsterdam, The Netherlands. Notably, ContraVir was notified by Dr.
Laurent Castera, EASL Secretary General, that the poster
elucidating the MOA of CRV431 was selected to be included in a
30-minute EASL “poster tour,” during which key global opinion
leaders guide delegates to selected posters related to HBV.
“The two EASL posters support ContraVir’s strategy of combining
two drug candidates with distinct and complementary modes of
action, an approach that may halt or slow the progression of
chronic hepatitis B virus,” said Robert Foster, Pharm.D., Ph.D.,
ContraVir’s Chief Scientific Officer. “We are especially gratified
to be included in one of the EASL poster tours, as the selection
reflects the EASL Scientific Programme Committee’s recognition of
CRV431 as an antiviral compound with a promising clinical profile
and a novel mode of action.”
TXL™, a potent prodrug of the successful antiviral agent
tenofovir, works by lowering infectious viral HBV DNA in the liver
and blood. CRV431, a cyclophilin inhibitor, complements the
activity of TXL™ by reducing levels of the hepatitis B surface
antigen (HBsAg), a viral protein that is a marker of HBV
infectivity and disease progression. CRV431 also impedes the
binding of HBx, another key HBV protein, to cyclophilin A, an
important cellular protein; together, HBx and HBsAg are considered
essential to hepatitis B viral replication, disease progression,
and pathogenesis of liver disease, including fibrosis and liver
cancer. The inhibitory effect of CRV431 on the binding of these
proteins as seen in in vitro testing potentially provides the
environment for the patient’s immune system to disable the HBV
virus and its products.
As part of today’s “HBV/HDV Experimental” EASL poster tour, Dr.
Foster provided an overview of a poster entitled, “The cyclophilin
inhibitor CRV431 prevents both cyclophilin A-HBx complex formation
and HBV replication.” The poster demonstrated that CRV431 appears
to exert an anti-HBV effect by interfering with the binding
interaction between HBx and cyclophilin A, thereby reducing HBV
replication.
In the other poster presentation, “CRV431 and CMX157: Anti-HBV
combination effects in vitro between a cyclophilin inhibitor and a
nucleotide prodrug,” Dr. Foster and colleagues reported that TXL™
and CRV431 synergistically suppress HBV DNA. Overall, the results
suggest that combining TXL™ and CRV431 can be a viable therapeutic
drug strategy, and that the two agents’ complementary actions may
reasonably extend to drugs with other modes of activity.
“The synergistic effects of TXL™ and CRV431 may bring us closer
to a ‘functional cure’ of HBV, whereby the virus remains suppressed
following completion of drug therapy,” commented Dr. Foster. “Our
combination approach may therefore facilitate progress toward the
goal of eradicating HBV, potentially relieving patients of the
worry of the long-term consequences of infection.”
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. One compound, TXL™ is an
analog of the antiviral drug Viread® (tenofovir disoproxil
fumerate), and is currently in Phase 2a of development. TXL™ has
demonstrated the potential for low, once-daily dosing and a low
systemic exposure, thereby potentially reducing renal and bone side
effects. 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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