December 10, 2014. AllaChem, LLC, announced today a successful completion of phase Ib/IIa clinical study with AV4025, a proprietary orally-bioavailable small molecule that blocks HCV genome replication by targeting viral non-structural protein NS5A. In a double-blind, placebo-controlled, randomized study of safety, tolerability, pharmacokinetics and antiviral activity of AV-4025 in HCV-infected patients, HCV- infected, treatment-naive subjects were randomized to receive 20 or 40 mg AV-4025 or placebo QD for 3 days (up to 10 subjects per cohort, drug:placebo ratio 4:1). The drug was safe and well-tolerated, no serious adverse effects were reported. All patients (HCV genotype 1b) had demonstrated rapid and strong antiviral response (median 3.35 log reduction of HCV RNA in 40 mg dose cohort).
Dr. Vadim Bichko, AllaChem’s Scientific Advisor, had presented the preliminary results of the study at the 17th Annual Meeting of the European Society for Clinical Virology, Prague, Czech Republic, September 29 – October 1, 2014.
Prof. Alexander Ivachtchenko, AllaChem’s CEO, stated, “We are very pleased with AV4025 antiviral efficacy and safety profile, demonstrated in this study. We plan to begin next clinical study with AV4025 in combination with other drugs in Q2 2015.”
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