February 4, 2025 / Clinical Trials,Research

Cumberland Pharmaceuticals Announces Positive Results from Phase 2 FIGHT DMD Trial of Ifetroban for Treatment of Duchenne Cardiomyopathy

Cumberland Pharmaceuticals Inc. has announced positive top-line results from its Phase 2 FIGHT DMD trial evaluating ifetroban for the treatment of Duchenne cardiomyopathy. Ifetroban is an oral thromboxane receptor antagonist aimed at reducing inflammation and fibrosis to protect cardiac function, and has received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA. Cumberland highlighted that the FIGHT DMD trial marks the first successful Phase 2 study specifically targeting cardiac complications in individuals with Duchenne.

The FIGHT DMD trial, which is the first Duchenne study to receive funding from the FDA Office of Orphan Products Development, is a 12-month, double-blind, randomized, placebo-controlled study. Results indicate that high dose ifetroban (300 mg per day) treatment resulted in an overall 3.3% improvement in left ventricular ejection fractions (LVEF) at 12 months, where the high dose ifetroban group showed an increase of 1.8% in LVEF and the placebo group showed an expected decline in LVEF of 1.5%. According to Cumberland, ifetroban is well-tolerated with no serious drug-related events.

PPMD is pleased to learn this news, with founding president and CEO Pat Furlong saying, “This trial represents hope for our Duchenne community. Heart disease remains one of the most devastating aspects of Duchenne, and these results suggest we may finally have a therapeutic option that could make a meaningful difference in the lives of patients and families.”

Cumberland reports that next steps include further data analysis and completion of a full study report in preparation for an end of Phase 2 meeting with the FDA to determine next steps associated with the product’s development and commercialization.

Read Cumberland’s press release here.

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