Last week, Xenon announced that they had received positive feedback from the FDA regarding the development of XEN901 that supported advancing XEN901 directly into a pediatric clinical trial examining its efficacy in pediatric patients with SCN8A epileptic encephalopathy (SCN8A-EE). This is important as most Anti-Epileptic Drugs (AEDs) have to be studied in adults before they are studied in pediatric populations.
Xenon is currently in the process of completing development of a pediatric-friendly formulation of XEN901 to support the study that will be compatible with feeding tubes. They will test the new formulation in healthy adults in a pharmacokinetic (PK) study, expected in the third quarter of this year.
The PK study is being performed to show that the new pediatric formulation behaves similarly to the adult formulation (which were capsules), which was tested in a Phase 1 trial in healthy adults earlier this year. After the PK study is complete, Xenon will be able to submit an IND to start a proposed Phase 2/3 clinical trial in SCN8A-EE patients.
We will update the families on the details about the final trial design, criteria, and endpoints, as they become disclosed over the coming months.