FDA to allow limb function endpoint in Capricor's DMD trials

Capricor Therapeutics Inc. (NASDAQ:CAPR) said it received minutes from an FDA meeting indicating the agency’s “willingness to accept" the Performance of the Upper Limb (PUL) outcome measure as a BLA-supportive primary efficacy endpoint in trials of Duchenne muscular dystrophy (DMD) candidate CAP-1002. This half, the company plans to start a Phase II trial of IV CAP-1002.

PUL is an instrument that measures patients' upper limb function at three levels -- the shoulder, elbow, and wrist and fingers -- while performing tasks such as weighted and unweighted movements, gripping and fine motor tasks, including picking up coins and tracing a path...