Xenon Pharmaceuticals Showcases Its XEN1101 Epilepsy Program at the 2023 American Academy of Neurology (AAN) Annual Meeting
Oral presentation by Dr.
Poster to present the trial design for Phase 3 X-ACKT clinical study evaluating XEN1101 in additional epilepsy indication of primary generalized tonic-clonic seizures
Mr.
2023 AAN Presentation Details:
Title: “XEN1101, a Novel Potassium Channel Modulator: Interim Data From an Ongoing, Long-Term, Open-Label Extension of a Phase 2b Study (X-TOLE) in Adults With Focal Epilepsy”
Format: Oral Presentation #008, Epilepsy/Clinical Neurophysiology (EEG): Epilepsy Outcomes
Presenter:
Date/Time:
Highlights:
- During the open-label extension (OLE), there was a sustained monthly reduction in seizure frequency (80%–90% seizure reduction as measured by median percent change) from the double-blind period baseline.
- Seizure freedom for ≥6-month and ≥12-month consecutive durations was achieved in 17.5% and 10.5% of patients, respectively.
- XEN1101 continues to be generally well-tolerated in the OLE with adverse events consistent with prior results and other anti-seizure medications.
Title: “A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of XEN1101 as an Adjunctive Therapy in the Treatment of Primary Generalized Tonic-Clonic Seizures”
Format: Poster Session 11, #012
Lead Author:
Date/Time:
Highlights:
- Xenon has initiated a Phase 3 clinical trial, called X-ACKT, to support potential regulatory submissions in an additional epilepsy indication of primary generalized tonic-clonic seizures (PGTCS).
- This multicenter, randomized, double-blind, placebo-controlled study will evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 160 patients with PGTCS.
- The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the double-blind period of XEN1101 compared to placebo.
Other AAN Activities:
On
In addition to the posters noted above, Xenon is hosting a booth (#1575) in the Exhibit Hall, which is scheduled to be open from
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Source: Xenon Pharmaceuticals Inc.