Capstone Therapeutics and LipimetiX Development, LLC announced the initiation of dosing for its AEM-28 (Apo E mimetic peptide) Phase 1 human clinical trial in LDL/non-HDL cholesterol reduction. The clinical study is a Phase 1a randomized, placebo-controlled, double-blinded, single center dose escalation study. The primary objectives are to evaluate safety and tolerability and to determine preliminary pharmacokinetics/pharmacodynamics of AEM-28 in normal healthy volunteers with elevated cholesterol.

Approximately 36 subjects are planned for treatment at a hospital-affiliated clinical site in Perth, Australia. The JV has a development plan to pursue regulatory approval of AEM-28 as treatment for Homozygous Familial Hypercholesterolemia (granted Orphan Drug Designation by FDA in 2012) and Severe Refractory Hypercholesterolemia. The initial development program will extend through Phase 1a and 1b/2a clinical trials and is expected to be completed in the fourth quarter of 2014.