ContraVir Pharmaceuticals Completes Final Cohort Dosing in CRV431 Drug-Drug Interaction Study
30 October 2018 - 11:00PM
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”),
today announced that it has completed dosing of the last cohort of
healthy subjects for its CRV431 drug-drug interaction (“DDI”)
study. The single-dose crossover study evaluated subjects
co-treated with Viread® (tenofovir disoproxil fumarate) (“TDF”), an
approved treatment for chronic HBV infection. The DDI study is the
second stage of CRV431's streamlined early clinical program, which
is agreed upon with the U.S. Food and Drug Administration (“FDA”).
“This DDI study will ensure that CRV431 can be
safely combined with other drugs HBV patients are likely taking,
particularly other antivirals,” said Dr. Robert Foster, Chief
Executive Officer of ContraVir. “We are looking forward to
generating favorable results, which would enable us to proceed to
the final stage of our early clinical program for CRV431, and
ultimately a Phase 2 clinical study.”
The DDI study follows the completion of the
first stage of the program, announced on September 18, 2018, where
CRV431 met the primary endpoints of safety and tolerability in a
single ascending dose (“SAD”) study of healthy volunteers. The DDI
study consists of three cohorts of the same 18 healthy volunteers.
The first cohort of subjects received a single oral dose of CRV431
based on the selected dose (“SD”) from the SAD, followed by a
20-day pharmacokinetic (“PK”) study and washout period. The second
cohort received 300mg of TDF followed by a six-day PK study and
washout period. The Company has now completed dosing of the final
cohort, where patients received both the SD of CRV431 and 300mg of
TDF. The patients will now undergo a final PK study and observation
period lasting 20 days, subject to availability of PK results.
ContraVir expects to report results of the DDI study prior to the
end of 2018.
With an FDA agreement of an accelerated clinical
program for CR431, ContraVir plans to bridge from the DDI study
into a multi-dose 28-day pilot in HBV patients, which will assess
the safety, tolerability, PK, and preliminary signals for antiviral
efficacy, as well as identify clinically-relevant biomarkers of
CRV431 with TDF.
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 such as
reducing liver fibrosis and hepatocellular carcinoma tumor burden.
For more information, please 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 December
30, 2017 and other periodic reports filed with the Securities and
Exchange Commission.
For further information, please contact:
Stephen KilmerContraVir Investor Relations(646)
274-3580skilmer@contravir.com
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