Praxis Precision Medicines, Inc. (NASDAQ:PRAX) shares are trading higher Monday after the company announced positive results from the EMBRAVE Part A Trial of Elsunersen in Patients with SCN2A Early-Onset Development and Epileptic Encephalopathy.
Trial Shows Significant Seizure Reduction
Praxis said elsunersen demonstrated a placebo-adjusted seizure reduction from baseline of 77% (p=0.015) in pediatric patients with SCN2A developmental and epileptic encephalopathy.
The company reported that 71% of elsunersen-treated patients achieved greater than 50% seizure reduction by period six, with efficacy sustained for up to one year in the open-label extension.
In addition, 57% of patients experienced at least a 28-day period of seizure freedom.
Praxis also noted that 100% of patients treated with elsunersen showed improvements in areas including sleep, motor function, muscle tone, attention or neuropsychomotor development, compared to no improvements in the placebo group.
Safety Profile Remains Favorable
Elsunersen was well-tolerated in the trial, with no treatment-emergent serious adverse events related to the study drug, no discontinuations and no signs of neuroinflammation at doses up to 8 mg.
Most treatment-emergent adverse events were mild to moderate and consistent with findings from the EMBRAVE Part 1 study.
Study Design And Next Steps
EMBRAVE Part A is a randomized, placebo-controlled Phase 1/2 trial evaluating ascending doses of elsunersen in patients aged 2 to 12 years old with SCN2A DEE.
Nine patients were randomized in a 3:1 ratio to receive elsunersen or a sham procedure every four weeks for 24 weeks, followed by an open-label extension, with all participants continuing into the extension phase.
Praxis said additional results from the trial will be presented at upcoming scientific meetings.
Praxis Shares Edge Higher
PRAX Price Action: At the time of publication, Praxis shares are trading 3.68% higher at $321.80, according to data from Benzinga Pro.
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