Cumberland Pharma Phase 2 ifetroban trial meets primary endpoint in DMD heart disease

CUMBERLAND PHARMACEUTICALS INC

High-dose ifetroban (300mg/day) produced 3.3% LVEF improvement vs placebo decline of 1.5%, net 4.8% benefit.
Comparison with propensity-matched natural history controls showed 5.4% overall LVEF improvement in high-dose group.
Both doses were well-tolerated; no serious drug-related events reported among 41 enrolled DMD patients.
Ifetroban holds FDA Orphan Drug and Rare Pediatric Disease Designations; first Phase 2 study for DMD heart disease.
Company plans end of Phase 2 FDA meeting to discuss development path; potential first therapy for DMD cardiomyopathy.

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