Biogen Launches Phase 3 Pediatric Trial Of Omaveloxolone For Friedreich Ataxia.

Biogen Inc. (NASDAQ:BIIB) is among the 11 Best Genomics Stocks to Buy According to Hedge Funds. It has begun dosing in the global Phase 3 BRAVE trial to test omaveloxolone (SKYCLARYS®) in children aged 2 to 16 with Friedreich ataxia (FA), a rare neurological illness.

About 255 participants will be included in the randomized, double-blind experiment, which will have a 52-week treatment duration and an open-label extension. SKYCLARYS is now the only approved therapy for FA in people aged 16 and up, and it is available in more than 40 countries. The BRAVE research seeks to address a large unmet need in pediatric FA.

FA is a crippling neuromuscular disease that is inherited and usually first manifests in childhood. Patients typically lose their ability to move within 10 to 20 years following the onset of symptoms, and the average age of death is 37. SKYCLARYS has shown effectiveness in adults and was designated as an Orphan Drug, Fast Track, and Rare Pediatric Disease.

The primary endpoint of the BRAVE research is the Upright Stability Score, which is part of the modified FA rating scale and is used to assess progression in children. Global enrollment is still ongoing.

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