Capricor's CAP-1002 misses Phase I/II heart repair endpoint
Capricor Therapeutics Inc. (NASDAQ:CAPR) reported data from a 6-month interim futility analysis of the Phase I/II ALLSTAR trial in 142 patients with residual cardiac dysfunction following a myocardial infarction (MI) showing that intracoronary CAP-1002 was unlikely to meet the primary endpoint vs. placebo. The primary endpoint of the double-blind, U.S. trial is evaluating the change from baseline to 12 months in infarct size as a percentage of left ventricular mass as measured by MRI. Capricor said reductions in scar size in the placebo arm exceeded reductions seen in natural history data. CAP-1002 non-significantly reduced mean end-diastolic volume and end-systolic volume from baseline to 6 months vs. placebo, but there was no difference between treatment arms in the change in ejection fraction.
Capricor plans to reduce the scope of its operations in order to focus primarily on developing CAP-1002, which consists allogeneic cardiosphere-derived stem cells, to treat Duchenne muscular dystrophy (DMD). The company said it is currently making determinations regarding a reduction in headcount as part of its reduced operations. Next half, Capricor plans to start a double-blind, placebo-controlled Phase I/II trial to evaluate the effects of IV CAP-1002 on skeletal muscle function in DMD patients...