Soticlestat continues to appear to be safe and well-tolerated; the majority of the 11 patients showed a reduction in seizures
All patients that have completed the Phase 2 ARCADE study to date have opted to enroll in the ENDYMION open-label extension study
In the Dup15q cohort (n=6), patients also exhibited a variety of seizures types including motor (tonic and atonic), myoclonic and absence seizures.
In one patient with pure motor seizures (34.8 seizures per 28-day baseline), seizure frequency was reduced by 90% during the 12-week maintenance phase (89% over the full treatment period). This patient also had two 28-day seizure-free periods.
The other five patients in the Dup15q cohort with mixed seizure types showed preliminary signs of efficacy, as follows:
° Three patients with myoclonic seizures showed a 60%, 66% and 100% reduction over the maintenance period (and by 74%, 65% and 100% respectively over the full treatment period).
° Two patients had absence seizures and showed a 78% and 74% reduction in absence seizures during the maintenance phase (74% and 51% reduction over the full treatment period). In the five patients that completed the full treatment period at the time of this data cut, motor seizure free days in four of these patients increased by 64%, 159%, 539% and 590%, the fifth patient did not show improvement.
Phase 2 ARCADE Study – Initial Safety Results
Soticlestat was generally well-tolerated in this study and demonstrated a safety profile consistent with the findings of previous studies. The most common adverse events were constipation (n=3; 27%), fatigue (n=2; 18%), nasopharyngitis (n=2; 18%) and seizure (n=2; 18%). Additionally, there were no adverse event-related withdrawals, serious adverse events or deaths reported.
