Stoke Therapeutics (STOK) said Tuesday it has reached alignment with global regulatory agencies on the design of its phase 3 trial of zorevunersen to treat Dravet syndrome.
The company said it has finalized the trial protocol after interactions with the US Food and Drug Administration, the EU's European Medicines Agency, and Japan's Pharmaceuticals and Medical Devices Agency.
The primary endpoint of the study will be a decrease in major motor seizure frequency, the company said, adding key secondary endpoints will include improvements in cognition and behavior. It plans to start the trial in mid-2025.
Stoke also said that zorevunersen has recently obtained US FDA's breakthrough therapy designation.
The company's shares were falling past 13% in recent trading.
Price: 9.52, Change: -1.50, Percent Change: -13.61
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