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Capricor Theraputicsannounces positive topline results from Pivotal Phase 3 Hope-3 study of Deramiocel in Duchenne Muscular Dystrophy
Capricor, which received early funding from CureDuchenne, announced today that HOPE-3 met its primary endpoint and a key cardiac secondary endpoint, with all Type 1 error–controlled secondary endpoints also achieving statistical significance. Deramiocel maintained a favorable safety and tolerability profile consistent with prior studies.
HOPE-3 is a randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating Deramiocel in boys and young men with Duchenne muscular dystrophy. The study randomized 106 participants across 20 leading U.S. clinical sites. Participants received intravenous Deramiocel at 150 million cells per infusion or placebo every three months for a 12-month period. The average age of participants was approximately 15 years, and all were on a stable corticosteroid regimen throughout the study. Baseline demographics were well balanced between treatment arms, approximately 90 percent were receiving cardiac medications at baseline, and over 75 percent had a clinical diagnosis of cardiomyopathy. Deramiocel maintained a favorable safety and tolerability profile consistent with prior clinical experience.
