- PTL’s Phase 2 open label clinical trial is aimed at measuring safety and efficacy of Satipharm CBD capsules for reducing seizure frequency in children with refractory, or treatment-resistant, epilepsy.
- Satipharm CBD capsules are a proprietary oral formulation developed using the Gelpell-CBD™ product technology.
- Satipharm CBD capsules reduced monthly seizure frequency in the treatment-resistant children when added to current medications. The treatment was generally well tolerated, with a safety profile consistent with prior experience.
- Promising evidence of efficacy has been reported. In 6 patients a reduction of 59-91% in mean monthly seizure frequency was observed following 12 weeks of treatment.
- The median reduction was -79.5% in the 12-week treatment period compared to the 4-week observation period.
Importantly, the initial results received to date indicate that Satipharm’s capsules significantly reduce monthly seizure frequency when added to current medications, with strong evidence of efficacy reported.
PTL’s near-term focus is on recruiting the final