XEN1101 for Epilepsy

XEN1101, A Selective KV7 Potassium Channel Modulator for the Treatment of Epilepsy

XEN1101 is a Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. We announced final data from the XEN1101 Phase 1 clinical trial and the related transcranial magnetic stimulation (TMS) studies at the American Epilepsy Society (AES) Annual Meeting in December 2018.

Based on the encouraging Phase 1 data and TMS results, Xenon has initiated a Phase 2b clinical trial in adult patients with focal epilepsy. A Clinical Trial Application (CTA) has been accepted by Health Canada enabling the start of patient screening, and the first patient in the XEN1101 Phase 2b clinical trial is expected to be enrolled in the near term. Xenon has also submitted regulatory filings to support the clinical development of XEN1101 in other jurisdictions, including the United States and Europe.

Clinical Development

The XEN1101 Phase 2b clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Depending upon the rate of enrollment, top-line results from the XEN1101 Phase 2 clinical trial are anticipated in the second half of 2020.    

About Focal Seizures

A focal seizure is localized within the brain and can either stay localized or spread to the entire brain, which is typically categorized as a secondary generalized seizure. Focal seizures are the most common type of seizure experienced by people with epilepsy. The treatment of an individual patient with focal seizures is currently focused on reduction of seizure frequency, with seizure freedom as the ultimate goal. Focal seizures (simple, complex and secondarily generalized tonic-clonic) account for approximately 60% of seizures (GlobalData Report 2017) of which approximately 33% are considered resistant to current treatments (Epilepsy Foundation). It is estimated that the addressable population in the United States could include approximately 460,000 adults and 70,000 pediatric epilepsy patients with refractory seizures.