Capricor Therapeutics (NASDAQ:CAPR) initiated dosing of first patient in HOPE-3, a Phase 3 clinical trial investigating CAP-1002 for treating late-stage Duchenne muscular dystrophy (DMD).

HOPE-3 study is designed to enroll approximately 70 patients in the United States. The participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.

The primary outcome measure of this Phase 3 study will be the Performance of the Upper Limb (PUL) 2.0, a validated tool specifically designed for assessing high (shoulder), mid (elbow) and distal (wrist and hand) function, with a conceptual framework reflecting weakness progression in upper limb function.

The FDA has previously granted Regenerative Medicine Advanced Therapy Designation (RMAT) as well as Orphan Drug Designation (ODD) to CAP-1002.

The company is eligible to receive a Priority Review Voucher in its regulatory pathway for CAP-1002 based on the designation as a rare pediatric disease.

Price Action : Capricor shares are trading around 5 percent higher at $4.58 on Tuesday at the time of publication.