AtheroNova Inc. announced today a significant milestone in completing the active treatment portion of its Phase 1 clinical trial with its lead compound, AHRO-001. The objective of the Phase I study is to evaluate AHRO-001’s safety, tolerability, and pharmacokinetics in volunteers who are healthy. This clinical study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova.
The design of the Phase 1 study is to characterize the safety of AHRO-001 through three dose ranges and possible pharmacokinetics, with a planned enrollment of 54 subjects. This multi-center, randomized, double-blind, placebo-controlled, single and multiple dose escalation, is the 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.
AHRO-001 is AtheroNova’s first application for the treatment and prevention of atherosclerosis. Atherosclerotic plaque, a buildup of fat, cholesterol, and other substances in the walls of arteries, is the main underlying cause of cardiovascular disease, including heart attacks, stroke, and peripheral artery disease (PAD). The Company has demonstrated positive results in animal models for regression of plaque and is beginning human studies in attempt to achieve the same results.
Lipid regulators, specifically statins, are today’s most effective products for reducing serum cholesterol levels, achieving blockbuster status with revenues of $33.6 billion in 2012 (Source: IMS Health, Inc.). However, at commonly prescribed dosage levels, they are ineffective at reducing plaque, and carry significant drawbacks related to their safety and tolerability.
In preclinical studies, AHRO-001 led to a 95% reduction in innominate arterial plaque formation versus a control group. Also, the compound has not shown morbidity, adverse effects, or mortality and was well tolerated at high doses.