AllaChem Announces a Successful Completion of Phase 1 Clinical Study With AV4025, a Potent Small Molecule HCV NS5A Inhibitor for the Treatment of Chronic Hepatitis C InfectionNovember 13, 2013
HALLANDALE BEACH, FL–(Marketwired – Nov 13, 2013) – AllaChem, LLC announced today a successful completion of phase 1 clinical study with AV4025, a proprietary orally-bioavailable small molecule that blocks HCV genome replication by targeting viral non-structural protein NS5A. A double-blind, placebo-controlled, single ascending oral dose study with AV4025 showed safety and tolerability in healthy volunteers. Each dose cohort (10 subjects per cohort) received a single dose of 10, 20, or 40 mg of AV4025, or placebo (drug: placebo ratio 4:1). The drug was safe, well-tolerated; and no significant adverse events (SAE) were reported. The pharmacokinetic analyses demonstrated high and dose-dependent drug exposure in plasma, as well as long half-elimination time, supportive of once daily dosing.
Prof. Alexander Ivachtchenko, AllaChem’s CEO, stated: “We are very pleased with the safety and pharmacokinetic profiles of AV4025 in this first-in-man study. Further clinical study with AV4025 is scheduled to begin in the HCV patients in Q1 of 2014.”