News & Events zu Stoke Therapeutics Inc (STOK)STOKStoke Therapeutics Inc

Stoke Therapeutics and Biogen Present Dravet Syndrome Data in Athens

"Stoke Therapeutics (STOK) and Biogen Inc. (BIIB) announced presentations of data at the 16th European Epilepsy Congress taking place September 5-9 in Athens, Greece. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. Dravet syndrome is a severe developmental and epileptic encephalopathy, DEE, characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Data presented at EEC represent more than 5 years of clinical experience with zorevunersen in patients with Dravet syndrome, including two Phase 1/2a and ongoing open-label extension studies. Four-year OLE results showed substantial and durable reductions in seizures and continuing improvements in cognition and behavior. A new exploratory sub-analysis also showed substantial reductions in the most severe seizure types, which are the leading risk factor for sudden unexpected death in epilepsy. SUDEP is the primary cause of premature death in Dravet syndrome2, and up to 20% of children and adolescents with the disease die before reaching adulthood3. An additional sub-analysis presented at EEC demonstrated substantial improvements in quality of life through 28 months in the OLEs. Zorevunersen continues to be generally well tolerated in the OLEs. The global, pivotal Phase 3 EMPEROR study is underway to evaluate the efficacy and safety of zorevunersen. Enrollment has completed in the planned primary analysis population, which will evaluate zorevunersen compared to sham administered via lumbar puncture (LP) in 162 patients enrolled in the U.S., U.K. and Japan. A Phase 3 data readout is anticipated in the third quarter of 2027 to complete the planned rolling New Drug Application to the U.S. Food and Drug Administration in the second half of 2027. Enrollment in Europe has also completed with 34 participants enrolled."

Stoke Therapeutics and Biogen Present Epilepsy Data in Athens

Stoke Therapeutics (STOK) and Biogen (BIIB) announced presentations of data at the 16th European Epilepsy Congress September 5-9 in Athens. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. The global, pivotal Phase 3 EMPEROR study is underway to evaluate the safety and efficacy of zorevunersen, and results are anticipated in 3Q27. Improvements in cognition and behavior were sustained through 4 years, in addition to durable seizure reductions and a generally well-tolerated safety profile. New exploratory sub-analyses show effects on the most severe seizure types, which are the leading risk factor for sudden unexpected death in epilepsy, as well as improvements in quality of life for patients treated with zorevunersen. Zorevunersen continues to be generally well tolerated, with some patients treated for more than 5 years in the Phase 1/2a and ongoing OLE studies. As of July 31, more than 930 doses have been administered.

Stoke Therapeutics Appoints Thomas McCauley as Chief Scientific Officer

Stoke Therapeutics announced that Thomas McCauley, Ph.D., has been appointed Chief Scientific Officer. McCauley most recently served as the President and Chief Executive Officer of Neptune Bio