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Alla Chem of Hallandale Beach, Florida, Announced Today a Successful Completion of Phase 1 Clinical Study With AV4025, a Potent Small Molecule HCV NS5A Inhibitor for the Treatment of Chronic Hepatitis C Infection



10/8/2013 8:47:17 AM

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October 7 , 2013 - AllaChem, LLC of Hallandale Beach, Florida (www.allachem.com), 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. In a double-blind, placebo-controlled, single ascending oral dose study of AV4025 safety and tolerability in healthy volunteers, each dose cohort (10 subjects per cohort) received a single dose of 10, 20, or 40 mg AV54025, or placebo (drug:placebo ratio 4:1). The drug was safe and well-tolerated, no serious adverse effects 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.

Dr. Vadim Bichko, AllaChem’s Scientific Advisor, had presented the results of the study at the 10th conference “Viral Hepatitis: Epidemiology, Diagnostics, Treatment and Prophylaxis”, Moscow, September 17-19, 2013.

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 development of the drug is warranted. We plan to begin next clinical study with AV4025 in the HCV patients in Q1 2014.

About AllaChem, LLC

The Florida-based company is a start-up focused on discovery and development of novel medicines to combat life-threatening viral infections, such as hepatitis C.

Contacts

Alena Ivachtchenko, MBA

Director of Business Development

Ph: 1(858) 357-6627

E-Mail: alena.ivachtchenko@allachem.com;

av@allachem.com

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