Catabasis' edasalonexent misses primary in Phase II for DMD

In April, Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) reported data from the Phase II portion of the U.S. Phase I/II MoveDMD trial in patients ages 4-7 with Duchenne muscular dystrophy (DMD) not on corticosteroids showing that edasalonexent (CAT-1004) missed the primary endpoint of improving muscle inflammation from baseline to week 12 vs. placebo. The endpoint was measured by MRI of leg muscles.

In the open-label Phase I portion, 17 patients received once-daily 33, 67 or 100 mg/kg oral edasalonexent for 7 days. In the double-blind, crossover Phase II portion, 31 patients, including 16 who completed treatment in the Phase I portion, received placebo or once-daily 67 or 100 mg/kg oral edasalonexent for 12 weeks. This quarter, Catabasis expects 24-week data from a 60-week, open-label extension to the trial. The company said all patients in the extension have moved to treatment with once-daily 100 mg/kg and that it plans to lengthen the extension by 52 weeks...