AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces achievement of a major milestone with the completion of the active treatment portion of its Phase 1 clinical trial with its lead compound, AHRO-001. The Phase 1 study objective is to evaluate the safety, tolerability and pharmacokinetics of AHRO-001 in healthy volunteers. The clinical study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova.
"We are pleased to have reached this critical milestone as we continue to make solid progress," stated Thomas W. Gardner, CEO of AtheroNova. "With top line data anticipated in the first quarter of 2014 we are excited about near and long term prospects."
The Phase 1 study, with a planned enrollment of 54 subjects, was designed to characterize the safety of AHRO-001 across three dose ranges and possible pharmacokinetics. It is a multi-center, randomized, double-blind, placebo-controlled, single and multiple dose escalation, first-in-human study of AHRO-001 administered via oral tablet to healthy adult volunteers at sites in Moscow and St. Petersburg, Russia. All subjects have been dosed and received either placebo or AHRO-001 in doses ranging from 18.75 mg/kg to 37.5 mg/kg per day. Top line data is expected to be announced in the first quarter of 2014.