Stoke, Biogen to present 4-year zorevunersen data at epilepsy congress

Stoke Therapeutics (NASDAQ: STOK) and Biogen (NASDAQ: BIIB) announced plans to present clinical data on zorevunersen, an investigational treatment for Dravet syndrome, at the 16th European Epilepsy Congress (EEC) in Athens, Greece, running September 5–9.

The presentations include the first medical meeting disclosure of 4-year results from ongoing Phase 1/2a open-label extension (OLE) studies. According to the companies, improvements in cognition and behavior were sustained through four years, alongside seizure reductions and a generally well-tolerated safety profile. New sub-analyses also examined effects on the most severe seizure types and patient quality of life.

Of the 81 patients enrolled in the Phase 1/2a studies, 93% continued into one of two OLE studies. As of the 4-year data cutoff, 77% of those patients remained enrolled. More than 930 doses have been administered as of July 31, 2026. Elevated cerebrospinal fluid protein values were observed in approximately 94% of patients, with 59% classified as treatment-emergent adverse events; no serious clinical manifestations or cases of hydrocephalus were reported.

Zorevunersen is an antisense oligonucleotide designed to increase functional NaV1.1 protein production by targeting the unaffected copy of the SCN1A gene, which is mutated in most cases of Dravet syndrome. The drug has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and orphan drug designation from both the FDA and the European Medicines Agency.

A global Phase 3 study, called EMPEROR, is currently underway, with results anticipated in the third quarter of 2027. Under a collaboration agreement, Stoke retains commercialization rights in the United States, Canada, and Mexico, while Biogen holds exclusive rights for the rest of the world.

The information in this article is based on a press release issued by Stoke Therapeutics and Biogen. Zorevunersen remains investigational and has not been approved by any regulatory authority.

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