ContraVir plans to begin a streamlined early clinical program to test the clinical safety and efficacy profile in healthy volunteers and HBV-infected patients.
ContraVir Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved the investigational new drug (IND) application for CRV431 for treatment of hepatitis B virus (HBV), initiating the clinical development program.
With the approval, the ContraVir aims to begin an early clinical program which will test the clinical safety and efficacy profile of CRV431 in healthy volunteers and patients infected with HBV in the US.
“The FDA’s approval of our development strategy in accelerating the clinical development of CRV431 allows us to move into patient trials in an expedited manner,” James Sapirstein, chief executive officer, ContraVir, said in a statement.
The clinical program aims to bridge from a single ascending dose treatment of healthy volunteers to a single dose drug-drug interaction study with tenofovir disoproxil fumarate (Viread), then ultimately into a multi-dose 28-day pilot in participants with HBV.
Conducted in the US, the randomized, partially-blinded, placebo-controlled study will consist of 3 parts.
The first, will assess the safety, tolerability and pharmacokinetic profile of CRV431 administered as a single dose in healthy volunteers. The second, will be a single dose drug-drug interaction pilot study conducted in stable HBV patients with CRV431 and cotreated with Viread. The last part of the study will assess the safety, tolerability, pharmacokinetic and preliminary signal for antiviral efficacy, identifying clinically-relevant biomarkers of CRV431 with Viread in stable patients with HBV.
CRV431, a non-immunosuppressive analog of cyclosporine A, plays a key role in protein folding, as its primary biochemical action is the inhibition of cyclophilin isomerase activity. Additionally, other viruses like HIV and hepatitis C virus similar use cyclophilin for its replication.
In preclinical studies, the drug has shown potential to complement current hepatitis B treatments in reducing multiple markers of infection including HBV DNA, HBsAG, HBx, HBeAg and HBV uptake by cells.