2:55 PM
Feb 13, 2018
 |  BC Extra  |  Clinical News

Catabasis gains on 60-week DMD data

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) was up $0.31 (25%) to $1.56 on Tuesday after reporting that edasalonexent (CAT-1004) preserved muscle function and slowed disease progression through 60 weeks of treatment in an open-label extension of the Phase I/II MoveDMD trial in steroid-naïve Duchenne muscular dystrophy patients ages four to seven. Catabasis reiterated its plans to start a Phase III trial this half in pediatric patients with DMD regardless of mutation type. Top-line data are expected in 2020.

At the time of analysis, all 13 boys continuing in the extension completed 48 weeks of treatment and eight completed 60 weeks. Catabasis said once-daily 100 mg/kg oral edasalonexent led to “consistent and clinically meaningful improvements” in the rate of decline of four muscle function assessments compared to a mean 39-week control period prior to receiving treatment. The muscle function assessments included three timed function tests (10-meter walk/run, 4-stair climb and time to stand) and the North Star Ambulatory Assessment (NSAA). Catabasis told BioCentury the trial was not powered for statistical significance on the assessments of muscle function.

Data will be presented on Saturday at the International Conference on Duchenne and Becker Muscular Dystrophy in Rome.

In January 2017, Catabasis reported data from MoveDMD's Phase II portion showing that once-daily 67 and 100 mg/kg oral edasalonexent missed the primary endpoint of improving muscle inflammation from baseline to week 12 vs. placebo. The company subsequently moved all patients to once-daily 100 mg/kg edasalonexent in the extension portion (see BioCentury Extra, Oct. 4, 2017).

Edasalonexent is a conjugate of salicylate and docosahexaenoic acid (DHA) that inhibits activated NF-kappa B (NF-kB).

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