Hepion Pharmaceuticals Inc (HEPA)

[Giovanni]

What date is this phase 3 study finished?

TIA!
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Phase 3 Study

ContraVir’s pivotal Phase 3 study seeks to compare Valnivudine™ to valacyclovir (Valtrex®) with shingles pain reduction as a primary endpoint.
Phase 3 Study Design

Multi-center, randomized, double-blind, parallel-group, comparative study (Valnivudine™ vs. valacyclovir)
Up to 200 centers (U.S. only)
Three-arm study: Valnivudine™ 400mg QD, Valnivudine™ 400mg BID, Valacyclovir 1000mg TID
985 patients estimated with 275 patients per arm
Patients aged 30 years and older
Seven day treatment period; follow up through day 120

Scientific Research

Pharmacokinetic data from completed Phase 1 and 2 clinical trials suggest that Valnivudine™ has the potential to demonstrate antiviral activity when dosed orally once-a-day at significantly lower blood levels than acyclovir, valacyclovir, and famciclovir, the FDA-approved drugs used for the treatment of shingles.