Xenon Pharmaceuticals is currently developing XEN496, which is a proprietary pediatric formulation of the active ingredient ezogabine, for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). Ezogabine was previously approved by the U.S. Food and Drug Administration (FDA), as an anti-epileptic drug as an adjunctive treatment for adults with focal seizures with or without secondary generalization. Xenon has received Fast Track designation and Orphan Drug Designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE from the FDA, as well as orphan medicinal product designation from the European Commission.
A Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial, called the “EPIK” study, is now underway to evaluate the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE. Dr. John Millichap is the Principal Investigator of the EPIK Study. The KCNQ2 Cure Alliance hosted a webinar on March 29, 2021, with Dr. Millichap to learn more about the EPIK clinical trial. A replay of the webinar can be found here. For more information about the EPIK study, please visit the clinical trial website* or email Lauren DeRienzo.
*Currently, the EPIK website is only accessible to people in the U.S. If you reside outside of the U.S., please email email@example.com for more information.