Capstone Therapeutics and its joint venture affiliate, LipimetiX Development, LLC, announced the completion of dosing and patient follow-up for its investigational AEM-28 (Apo E mimetic peptide) Phase 1a human clinical trial in cholesterol and lipid reduction. The Medical Safety Committee, reviewing all safety-related aspects of the clinical trial, observed an acceptable safety profile. As a first-in-man study, the primary endpoint was safety, yet, biomarker efficacy measurements analyzing pharmacodynamics yielded trends favoring AEM-28 versus placebo in multiple cholesterol and lipid endpoints.

The clinical study, performed at a hospital-affiliated clinical research site in Perth, Australia was a Phase 1a randomized, placebo-controlled, double-blinded study testing six escalating single doses of AEM-28. There were six patients (including two placebo and four active) in each of the dosing cohorts for a total of 36 subjects. The patients fasted and were given an industry standard pre-medication regimen prior to IV administration of study drug.

Follow up occurred over a fourteen day time frame. The primary objectives were to evaluate safety and tolerability and to determine preliminary pharmacokinetics/pharmacodynamics of AEM-28 in normal healthy volunteers with elevated cholesterol. The Phase 1a study sequenced into a Phase 1b/2a multiple ascending dose study testing the three higher doses from Phase 1a.

The Phase 1b/2a study is testing five patients (including one placebo and four active) in each of the dosing cohorts for a total of 15 subjects. Administration of placebo and study drug will occur at three intervals two weeks apart. The patient population, initially targeted for refractory hypercholesterolemics, has been expanded to include normal healthy volunteers with elevated cholesterol and high Body Mass Index in order to facilitate enrollment.

All clinical aspects and study objectives are the same as the Phase 1a study.