Stoke and Biogen publish data showing Dravet syndrome severity

Stoke Therapeutics (NASDAQ: STOK) and Biogen Inc. (NASDAQ: BIIB) announced publication of data from the BUTTERFLY study, a two-year natural history study of Dravet syndrome patients. The research was published in Neurology, the medical journal of the American Academy of Neurology.

The study tracked 23 children and adolescents ages 2 to 18 with Dravet syndrome, a severe epileptic condition caused by mutations in the SCN1A gene. Despite treatment with standard anti-seizure medications, patients showed minimal cognitive and behavioral development over the two-year period.

Key findings showed neurodevelopment plateaued at approximately two years of developmental age regardless of when patients entered the study. Major motor seizure frequency increased by 10.6 percent over two years, with patients averaging 14.3 seizures per 28 days at baseline.

The study used assessment tools including the Vineland Adaptive Behavior Scale, Bayley Scales of Infant Development, and Wechsler Preschool and Primary Scale of Intelligence. These same measures are being used as endpoints in the companies' Phase 3 EMPEROR study evaluating zorevunersen, an investigational treatment for Dravet syndrome.

"These natural history data confirm that the life-altering effects of Dravet syndrome extend well beyond seizures," said Joseph Sullivan, lead author and professor at the University of California San Francisco.

Dravet syndrome affects an estimated 38,000 people in the U.S., UK, EU-4 and Japan. More than 90 percent of patients continue experiencing seizures despite treatment with available anti-seizure medications. Up to 20 percent of children and adolescents with the condition die before adulthood.

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