Cumberland Pharmaceuticals (NASDAQ: CPIX) announced breakthrough results from its Phase 2 FIGHT DMD clinical trial, presented at the Muscular Dystrophy Association Conference. The study evaluated ifetroban for Duchenne muscular dystrophy (DMD) heart disease.
Key findings showed that high-dose ifetroban treatment achieved a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo. When compared to natural history controls, the improvement was even more significant at 5.4%, while control patients showed a 3.6% LVEF decline.
Ifetroban, an oral thromboxane receptor antagonist, has received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for DMD-related heart disease. The company is preparing for an end-of-Phase-2 meeting with the FDA to discuss development and commercialization next steps.
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