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Wednesday, Biogen Inc. (NASDAQ:BIIB) revealed topline data from the pivotal cohort (Part B) of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of a higher dose regimen of nusinersen in treatment-naïve, symptomatic infants with spinal muscular atrophy (SMA).
The investigational higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and a higher maintenance regimen, 28 mg, every four months, compared to the approved nusinersen 12 mg regimen (Spinraza).
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The study met its primary endpoint at six months, achieving a statistically significant improvement in motor function in infants who received the higher dose regimen compared to a prespecified matched sham (untreated) control group from the ENDEAR study.
“The encouraging topline results from DEVOTE show that the higher dose regimen can slow neurodegeneration faster, as shown by greater reductions in neurofilament at day 64 relative to the approved dose. Over time, the higher dose regimen led to meaningful clinical benefit in infants with symptomatic SMA,” said Stephanie Fradette, Head of the Neuromuscular Development Unit at Biogen.
Results favored the higher dose regimen relative to sham across secondary endpoints and trended in favor of the higher dose regimen over the currently approved 12mg regimen on key biomarker and efficacy measures.
The higher dose regimen was generally well tolerated, with reported adverse events generally consistent with SMA and the known safety profile of nusinersen.
Spinraza is approved in more than 71 countries to treat infants, children, and adults with spinal muscular atrophy (SMA).
As a foundation of care in SMA, more than 14,000 individuals have been treated with Spinraza worldwide.
Price Action: At last check on Wednesday, BIIB stock was up 0.76% to $206.40.
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