Capstone Therapeutics and its joint venture affiliate, LipimetiX Development, LLC announced the initiation of dosing for the AEM-28 (Apo E mimetic peptide) Phase 1b/2a human clinical trial in refractory hypercholesterolemic subjects who are already on optimal cholesterol lowering therapy but are unable to reach target cholesterol levels. This clinical study is the Multiple Ascending Dose component of a blended Phase 1/2 randomized, placebo-controlled, double-blinded, single center dose escalation study. The Single Ascending Dose component of the study, in healthy volunteers with elevated cholesterol, began on April 8, 2014, and has progressed through the first 5 out of 6 cohorts.

The blended study design called for initiation of the MAD component after establishing safety and tolerability in the first 5 cohorts from the SAD. The primary objectives of the MAD are to evaluate safety and to determine preliminary pharmacokinetics/pharmacodynamics of 3 repeated administrations of AEM-28 using the 3 high doses tested in the SAD. Approximately 15 subjects are planned for treatment at a hospital-based clinical site in Perth, Australia.