Biogen Dips on Its Part in BRAVE Study

Biogen Inc. (NASDAQ: BIIB) lost strength in Wednesday trading, after the Cambridge, Mass.-based company announced the initiation of dosing in the BRAVE study, a global Phase 3 clinical trial.

The BRAVE study will evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) between the ages of two and <16. Both non-ambulatory and ambulatory participants may qualify for the study.

This morning’s news release reported that participants will be randomized 2:1 to receive omaveloxolone or placebo once a day for 52 weeks before having the opportunity to move into the open-label extension (OLE).

Currently, omaveloxolone is commercialized under the brand name SKYCLARYS® in over 40 countries, including in the U.S. and the European Union, and is the only approved product for FA in adults and adolescents aged 16 years and older.

“Recognizing the symptoms of Friedreich ataxia typically begin in childhood, and earlier onset of symptoms is associated with faster disease progression, there is tremendous unmet need in the pediatric community. Building on the work of Reata we have been urgently advancing the pediatric development plan for omaveloxolone and are thrilled that the Phase 3 BRAVE study has now begun,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular Development Unit at Biogen.

“We are immensely grateful for the input from the entire FA community that has helped shape the design of this important study.”

BIIB shares slid 44 cents to begin Wednesday at $126.12.