Stoke Reports Safety And Efficacy Data From Phase 1/2a Studies Of STK-001 In Dravet Syndrome

(RTTNews) - Stoke Therapeutics, Inc. (STOK) Tuesday reported positive safety and efficacy data from two Phase 1/2a studies of its drug candidate STK-001 for the treatment of Dravet syndrome. However, shares were down more than 29% in pre-market.

Data from Phase 1/2a studies dubbed MONARCH in the US and ADMIRAL in the UK showed that STK-001 was generally well-tolerated among 74 patients aged 2 to 18 years, and there were no discontinuations related to study drug.

32% of patients experienced a treatment-emergent adverse event, and 20% had a treatment-emergent serious adverse event.

Results from the Phase 1/2a ADMIRAL Study showed that patients treated with 2 or 3 initial doses of STK-001 experienced substantial and sustained reductions in convulsive seizure frequency.

Data from an open-label extension (OLE) study dubbed SWALLOWTAIL showed sustained reductions in convulsive seizure frequency and improvements in cognition and behavior after treatment with STK-001 in children and adolescents with Dravet syndrome.

The company plans to complete these studies by year-end and additional data are expected in the first quarter of 2024.

Stoke shares closed at $9.53, down 20.52%. The stock has been trading in the range of $6.88 - $22.87 in the last 1 year.