ContraVir Pharmaceuticals Announces Completion of Phase 1 With CRV431
ContraVir Pharmaceuticals, Inc. recently announced 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 toward 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. 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.
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, visit www.contravir.com.
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