Edasanolexent (CAT-1004), a nonsteroidal anti-inflammatory drug tested in DMD, broke promises: development halts after several clinical trials

On October 26, 2020, the Catabasis pharmaceuticals laboratory announced in a press release the interruption of the clinical program evaluating edasalonexent in Duchenne muscular dystrophy. Edasanolexent is a combination of two bioactive substances, salicylic acid (aspirin) and docosahexaenoic acid, an omega-3 fatty acid. It is thought to act on the NF-KB protein, to decrease inflammation and slow down the dystrophic process.

Good tolerance but no motor effect
In its press release, Catabasis presents the results of PolarisDMD, an international phase III double-blind placebo-controlled trial that involved 131 boys with DMD aged 4 to 7 years who were not receiving steroid treatment.
Edasanolexent is well tolerated with no negative effects on children’s growth or bone health. But after a year of treatment, walking ability has not significantly increased, according to the measures of the NSAA (North Star Ambulatory Assessment) and those collected in the walking or running tests (speed to stand up or walk 10 meters, or climb 4 steps).

 

Access Catabasis Pharmaceuticals press release (26 Oct 2020) « Catabasis Pharmaceuticals Announces Top-Line Results for the Phase 3 PolarisDMD Trial of Edasalonexent in Duchenne Muscular Dystrophy »