ContraVir Pharmaceuticals Reports Progress in Phase 1/2A Trial of CRV431
July 23 2018 - 8:00AM
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 it has completed dosing of the first cohort in
Part 1 of the Phase 1/2A trial of CRV431. Preliminary data
from the first completed cohort suggest that CRV431 is safe and
well-tolerated. The pharmacokinetic (PK) profile following oral
dosing indicates that systemic exposures of CRV431 are in-line with
anticipated exposures from completed pre-clinical studies.
“Initial data from the first dosing cohort in Part 1 of the
Phase 1/2A trial of CRV431 was encouraging, with results indicating
the drug is safe and yields a pharmacokinetic profile suggesting
favorable oral bioavailability,” said James Sapirstein, Chief
Executive Officer of ContraVir. “While early, these results give us
confidence as we continue to advance and accelerate the development
efforts for CRV431 with the goal of delivering an all-oral
combination treatment for the functional cure of hepatitis B virus.
CRV431 belongs to a novel class of host-targeting compounds that,
to date, have not been used clinically to treat HBV infections and
we are excited to further explore its potential in the clinic.”
The Phase 1/2A trial of CRV431 is designed as a randomized,
partially-blinded, placebo-controlled study consisting of three
parts. Part 1 of the study is intended to assess the safety,
tolerability, and PK profile of CRV431 when administrated as a
single oral dose in healthy volunteers. Part 2 of the
clinical trial will consist of a single dose of CRV431, in
combination with standard-of-care tenofovir disoproxil fumarate
(marketed by Gilead as Viread®,TDF) to determine the safety,
tolerability and PK. Part 3 of the study will assess the
safety, tolerability, PK and antiviral efficacy of CRV431 in stable
HBV patients currently receiving a daily regimen of TDF.
About CRV431CRV431 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, 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. CRV431 is currently the subject of a Phase 1 clinical
trial testing clinical safety and efficacy in healthy volunteers
and HBV patients.
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 31,
2017 and other periodic reports filed with the Securities and
Exchange Commission.
For further information, please contact: Sharen
Pyatetskaya Director of Investor Relationssp@contravir.com; +1
(732) 902-4028
Contravir Pharmaceuticals Inc (NASDAQ:CTRV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Contravir Pharmaceuticals Inc (NASDAQ:CTRV)
Historical Stock Chart
From Apr 2023 to Apr 2024