Stoke Therapeutics Posts Encouraging Interim Safety Data From Early-Stage Dravet Syndrome Trial
- Stoke Therapeutics Inc (NASDAQ: STOK) announced interim analysis data from Phase 1/2a MONARCH study of STK-001 in children and adolescents with Dravet syndrome.
- The interim analysis is based on data from 21 patients who were treated in the single 10mg (n=5), 20mg (n=4), or 30mg (n=6) dose cohorts.
- A dose-proportional increase in study drug exposure was observed in plasma pharmacokinetics.
- Cerebrospinal fluid (CSF) exposure was measurable up to six months following a single intrathecal dose.
- A dose-proportional increase in CSF concentration was observed from 20mg to 30mg.
- Based on data available from 11 patients in the single ascending doses cohorts, 8 out of 11 patients demonstrated a reduction in convulsive seizure frequency.
- The most common treatment-emergent adverse events were headache, irritability, vomiting, seizure, and back pain.
- Following recent interactions with the FDA related to the partial clinical hold on higher dose levels in the MONARCH study, the FDA will allow Stoke to add a higher dose level (45mg) to the SAD and MAD portions of the MONARCH study.
- The Company expects to share clinical data from multiple doses of 30mg in 2H of 2022.
- The Company will provide greater detail on data from the MONARCH study at the American Epilepsy Society annual meeting in December.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: STOK stock is up 6.60% at $25.21 during the market session on the last check Tuesday.
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