ContraVir Pharmaceuticals Announces Completion of Phase 1 with CRV431
September 18 2018 - 9:00AM
ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical
company focused on the development and commercialization of
therapeutic drugs for the treatment of hepatitis B virus (HBV),
announced today that the primary endpoints of safety and
tolerability were met in a single ascending dose (SAD) study of
CRV431 conducted in the United States.
Subjects in the study were treated with escalating doses of
CRV431 administered as a single dose. In addition to a
favorable safety and tolerability profile, pharmacokinetic (PK)
profiling demonstrated CRV431 exposure levels that are anticipated
to be efficacious in future HBV patient studies.
“We are extremely pleased with the PK results in this study
indicating good exposure to CRV431,” said James Sapirstein, Chief
Executive Officer of ContraVir. “The positive results from this
trial support the continued development of CRV431 in a Phase 2
clinical efficacy study. Continued progress of our CRV431 clinical
program allows ContraVir to drive towards its goal of participating
in a curative regimen for Hepatitis B in a streamlined development
program as announced earlier this year.”
As a first in class host targeting candidate medicine, CRV431 is
expected to complement other anti-HBV viral agents.
About CRV431 CRV431 is a non-immunosuppressive
analog of cyclosporine A (CsA) whose primary biochemical action is
inhibition of cyclophilin isomerase activity, playing a key role in
protein folding. Other viruses such as HIV-1 and HCV, similarly use
cyclophilin for their replication. In pre-clinical studies, CRV431
has shown potential in experimental models to complement current
hepatitis B treatments by reducing multiple markers of infection
including HBV DNA, HBsAg, HBx, HBeAg, and HBV uptake by cells.
Studies have also demonstrated that CRV431 reduces the progression
of fibrosis in an animal model and also reduces both the number and
size of liver tumors in a hepatocellular carcinoma (HCC) model.
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 oral therapy for
hepatitis B virus (HBV). The company is developing two novel
anti-HBV compounds with complementary mechanisms of action. TXL™, a
direct acting antiviral (DAA) nucleotide analog lipid prodrug of
tenofovir (TFV), is designed to deliver higher hepatic
intracellular concentrations of the active tenofovir species
(tenofovir diphosphate) while reducing concentrations of tenofovir
outside the liver, causing fewer off-target toxicities and
side-effects. CRV431, the other anti-HBV compound, is a
host-targeting antiviral (HTA) next-generation cyclophilin
inhibitor with a novel chemical structure that optimizes the
selective index against HBV. In vitro and in
vivo studies have thus far demonstrated that CRV431 reduces
HBV DNA and other viral proteins, including surface antigen
(HBsAg), while offering additional benefits to mitigate liver
disease. For more information, please
visit www.contravir.com.
Forward Looking StatementsCertain 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-KT for the year ended December 30,
2017 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; +1
(732) 902-4028
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