CardioNova initiates Phase 1b clinical trial with AtheroNova's AHRO-001
Published on July 30, 2014 at 9:21 AM
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 that its partner, CardioNova, has accomplished first dosing of subjects for its Phase 1b clinical trial with AtheroNova's lead compound, AHRO-001. This Phase 1b trial will be a continuation of the AHRO-001 Phase 1 safety trial completed in February 2014, in which patients were dosed with AHRO-001 for up to three weeks. The Company will remain blinded to data from the earlier Phase 1 cohorts until the completion of Phase 1b, at which time the topline data will be presented together in approximately six to eight months.
"We are pleased to announce this important milestone for AtheroNova's clinical development program," said Thomas W. Gardner, Chairman and Chief Executive Officer of AtheroNova. "Much of what would typically be studied in later phase clinical trials will be available to us in this Phase 1b trial on an accelerated basis at a lower cost. We will study the pharmacokinetic and pharmacodynamic effects of twelve weeks of drug administration. We will look at markers for inflammatory response, statin interaction and reverse cholesterol transport, among others. This study will generate a wealth of information in the near term as we anticipate topline data in 6-8 months."
The Phase 1b study will enroll 48 subjects to assess the safety, tolerability and pharmacokinetics of AHRO-001 administered orally three times daily in graduated dosing to both statin treated and statin naïve, hypercholesterolemic individuals. The study will evaluate lipid profiles, define gastrointestinal tolerability and pharmacokinetics of graduated dosing for active transport stimulation; as well as the hepatic cholesterol synthesis and pharmacokinetics of co-administration of a statin with AHRO-001 in some of the subjects in the study.