02:42 PM EDT, 03/26/2024 (MT Newswires) -- Stoke Therapeutics ( STOK ) shares were up 68% in recent Tuesday trading, a day after the company reported its investigational new medicine STK-001 was found to benefit subjects with Dravet syndrome, a severe myoclonic epilepsy of infancy.
STK-001 was shown to reduce seizures and improve multiple measures of cognition and behavior in two open-label Phase 1/2a studies and two open-label extension studies of children and adolescents between 2 to 18 years.
The phase 1/2a end of study data showed median reductions of 85% at three months and 74% at six months after last dose in subjects who received 70 milligram of STK-001. The reductions were observed in subjects who were already taking the best available anti-seizure medicines, the company said.
Stoke said it also received clearance from the US Food and Drug Administration to administer three doses of 70mg, followed by continued dosing at 45mg. As a result, the company said it was planning to discuss with regulatory agencies a registrational study that includes initial doses of 70 milligram followed by continued dosing at 45 milligrams.
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