Cumberland reports ‘positive’ results from Phase 2 FIGHT DMD trial

Cumberland (CPIX) Pharmaceuticals announced positive top-line results from its Phase 2 FIGHT DMD trial. The study evaluated ifetroban, a novel oral therapy for Duchenne muscular dystrophy heart disease – the leading cause of death in DMD patients. It marks a breakthrough for these patients, as it’s the first successful Phase 2 study specifically targeting the cardiac complications of their condition. Key findings include: High dose ifetroban treatment resulted in an overall 3.3% improvement in LVEF. The high dose ifetroban group showed an increase in 1.8% in LVEF, while the study placebo group showed an expected decline in LVEF of 1.5%.When compared with propensity matched natural history controls, the difference was even more pronounced, with the high dose treatment providing a significant 5.4% overall improvement in LVEF, as the control patients experienced a 3.6% decline in LVEF. Both doses of ifetroban were well-tolerated, with no serious drug-related events. “The cardiac imaging data from this trial is compelling,” noted Jonathan Soslow, MD, Professor of Pediatrics, Vanderbilt University, pediatric cardiologist and cardiac imaging expert. “The preservation and even improvement in cardiac function seen with ifetroban treatment stands in stark contrast to the expected decline we typically observe in untreated DMD patients.”