Stoke Therapeutics Stock Falls Post Early Efficacy Data From Lead Dravet Syndrome Program

  • Stoke Therapeutics Inc STOK announced data from a planned interim analysis of the ongoing Phase 1/2a MONARCH and ADMIRAL clinical studies of STK-001 in children and adolescents with Dravet syndrome. 
  • Today's results come almost a year after Stoke touted its first-in-human data for STK-001.
  • In addition to positive safety, pharmacokinetic (PK) and cerebrospinal fluid (CSF) exposure data, median reductions in seizure frequency were observed among patients who were treated with multiple doses of STK-001 (20mg, 30mg and 45mg). 
  • In a subgroup of six patients examined at the highest dose (45mg) so far — who had all received three doses — Stoke observed a median 55% reduction in convulsive seizure frequency. 
  • The reduction was seen between four weeks after patients received their first 45 mg dose and three months after receiving their third dose. They were among a total of 55 patients who had received at least one drug dose at any level.
  • The 20 and 30 mg doses performed numerically worse than the 45 mg in Monday’s data cut. In four patients who took three 20 mg doses, Stoke saw a median 41% reduction from baseline, while in 17 patients at the three-dose 30 mg level, researchers saw only a 20% median reduction.
  • Stoke had approximately $252.2 million in cash, cash equivalents, marketable securities, and restricted cash, which is anticipated to fund operations into 2025.
  • STOK reported a widened net loss for Q3 of $(26.1) million, or $(0.66) per share, versus $(22.6) million, or $(0.61) per share a year-ago.
  • Price Action: STOK shares are down 26.10% at $9.23 on the last check Monday.
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