ContraVir Pharmaceuticals (NASDAQ:CTRV) 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, an approved treatment for chronic HBV infection. The DDI study is the second stage of the streamlined FDA-approved clinical program for CRV431.
“This DDI study will ensure that CRV431 can be safely combined with other drugs HBV patients are likely taking, particularly other antivirals,” Dr. Robert Foster, CEO, said in a statement.
“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,” he added.
The DDI study follows the completion of the first stage of the program, announced on Sept. 18, 2018, where CRV431 met the primary endpoints of safety and tolerability in a single ascending dose study of healthy volunteers.
The patients in the DDI study will now undergo a final pharmacokinetic (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 Viread.
