Stoke completes enrollment for Dravet syndrome Phase 3 study
- Stoke Therapeutics completed enrollment of 162 patients in its Phase 3 EMPEROR study of zorevunersen.
- The company plans a rolling FDA NDA submission starting in Q1 2027, with data expected in Q3 2027.
- The study evaluates zorevunersen as a potential disease-modifying treatment for Dravet syndrome.
Stoke Therapeutics Inc. (NASDAQ:STOK) said it has completed enrollment of 162 patients in its Phase 3 EMPEROR study of zorevunersen, an investigational RNA medicine for Dravet syndrome.
The company said it plans to begin a rolling New Drug Application submission to the U.S. Food and Drug Administration in the first quarter of 2027.
A Phase 3 data readout is expected in the third quarter of 2027, with completion of the rolling NDA submission targeted for the second half of 2027.
“The rapid enrollment of the Phase 3 EMPEROR study reflects the severity of Dravet syndrome,” said Stoke Therapeutics Chief Executive Officer Ian F. Smith.
Stoke Therapeutics said about 50 of the 162 patients have reached the 28-week treatment point used to measure the primary endpoint of seizure frequency.
Following the announcement the Stoke Therapeutics share price was unchanged at $--.
The company also said no patients have discontinued treatment in the study, and an additional 30-patient cohort is enrolling in Europe.
Stoke Therapeutics said zorevunersen is designed to restore protein expression by targeting the underlying genetic cause of Dravet syndrome.
FAQ
Why did Stoke Therapeutics Inc. (NASDAQ:STOK) complete enrollment in the EMPEROR study?
Stoke Therapeutics Inc. (NASDAQ:STOK) completed enrollment of 162 patients to support its Phase 3 evaluation of zorevunersen in Dravet syndrome. The company said enrollment finished in about 10 months due to strong patient and investigator participation.
What is Stoke Therapeutics Inc. (NASDAQ:STOK) testing in the EMPEROR study?
Stoke Therapeutics Inc. (NASDAQ:STOK) is testing zorevunersen, an RNA medicine designed to treat Dravet syndrome by restoring protein expression and reducing seizure frequency.
When does Stoke Therapeutics Inc. (NASDAQ:STOK) expect FDA submission for zorevunersen?
Stoke Therapeutics Inc. (NASDAQ:STOK) plans a rolling FDA New Drug Application submission starting in Q1 2027. The company expects to complete the submission in the second half of 2027.
What results will determine Stoke Therapeutics Inc. (NASDAQ:STOK) regulatory filing?
Stoke Therapeutics Inc. (NASDAQ:STOK) said Phase 3 data expected in Q3 2027 will support completion of the rolling NDA submission. The primary endpoint is change in major motor seizure frequency at 28 weeks.
How many patients are in the Stoke Therapeutics Inc. (NASDAQ:STOK) Phase 3 study?
Stoke Therapeutics Inc. (NASDAQ:STOK) enrolled 162 patients in the main Phase 3 EMPEROR study, with an additional 30-patient cohort currently enrolling in Europe.
SEO Section
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Meta title:
Stoke completes Phase 3 enrollment for Dravet drug study
Meta description:
Stoke Therapeutics (NASDAQ:STOK) completed Phase 3 EMPEROR enrollment for zorevunersen and plans rolling FDA NDA submission in 2027.
Meta image description:
Clinical trial and neuroscience imagery representing Stoke Therapeutics RNA medicine zorevunersen targeting Dravet syndrome and Phase 3 study progress.
Keywords:
Stoke Therapeutics, STOK, zorevunersen, Dravet syndrome, EMPEROR study, Phase 3 trial, RNA medicine, FDA NDA submission, seizure frequency, genetic disease treatment, biotechnology clinical trial.
