Catabasis Reports Edasalonexent Fails to Achieve Primary Endpoint in Phase 3 Duchenne Muscular Dystrophy Trial

Catabasis Reports Edasalonexent Fails to Achieve Primary Endpoint in Phase 3 Duchenne Muscular Dystrophy Trial

Catabasis Pharmaceuticals announced top-line results from the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD). The trial did not meet the primary endpoint, which was a change from baseline in the North Star Ambulatory Assessment (NSAA) over one year of edasalonexent compared to placebo. The secondary endpoint timed function tests (time to stand, 10-meter walk/run and 4-stair climb) also did not show statistically significant improvements. Edasalonexent was generally safe and well-tolerated in this trial. Catabasis is halting the development of edasalonexent, including the ongoing GalaxyDMD open-label extension trial. Data from the PolarisDMD trial will be further analyzed and are expected to be presented at an upcoming scientific conference and published.

PolarisDMD was a one-year placebo-controlled trial designed to evaluate the safety and efficacy of edasalonexent in boys ages 4-7 with DMD. The global trial enrolled 131 boys across eight countries, with any mutation type, who were not on steroids. Edasalonexent was well-tolerated. The majority of adverse events were mild in nature and the most common treatment-related adverse events were diarrhe...

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