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Capricor Therapeutics to Meet With FDA to Discuss CAP-1002 to Treat Duchenne Muscular Dystrophy
Capricor Therapeutics, a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment of Duchenne muscular dystrophy (DMD) and other rare disorders, announced today that it has been granted a Type B End-of-Phase 2 meeting with the FDA to discuss prespecified interim analysis of the Company’s HOPE 2 clinical trial, which was reported in July of this year. The trial is a double-blind, placebo-controlled study of the company’s therapy, CAP-1002, in steroid-treated boys and young men in the later stages of DMD, a fatal genetic disease with few treatment options. The pre-specified interim analysis was performed on the six-month follow-up.
Per FDA’s interpretation of Section 506(g) of the federal Food, Drug and Cosmetic Act, which was added by the 21st Century Cures Act enacted in 2016, therapies with an RMAT designation may be eligible for accelerated approval based on previously agreed-upon intermediate endpoints that are reasonably likely to predict long-term clinical benefit.
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