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Abstract Details

Interim Long-term Safety and Efficacy of XEN1101, a Potent, Selective Potassium Channel Opener: Update from an Ongoing Open-label Extension of a Phase 2b Study (X-TOLE) in Adults with Focal Epilepsy
Epilepsy/Clinical Neurophysiology (EEG)
S19 - Epilepsy Clinical Trials and Long-term Studies (4:18 PM-4:30 PM)
005
To report interim 18-month data from an ongoing, long-term, open-label extension (OLE) of a Phase 2b study (X-TOLE) of XEN1101 in adults with focal onset seizures (FOS).
In the double-blind period (DBP) of X-TOLE, XEN1101 (10, 20, and 25 mg QD with food) showed a dose-dependent, statistically significant, and rapid-onset reduction in seizure frequency. We report interim 18-month OLE safety and efficacy data. 
Eligible patients enrolled in the 5-year OLE at 20 mg QD with food. Assessments occurred at week 3 in the OLE and at 3-month intervals thereafter. Safety assessments included treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Primary efficacy outcome was median percentage change (MPC) in monthly (28-day) FOS frequency from DBP baseline. 
285 patients completed the DBP and 275 (96.5%) enrolled in the OLE. At the 18-month OLE interim analysis (April 12, 2023), 182 had been treated for ≥1 year and 170 for ≥18 months; 159 (57.8%) patients continued participation. The majority of TEAEs were mild or moderate. The most common TEAEs were dizziness, coronavirus infection, headache, fall, and somnolence. 20.7% reported TEAEs leading to dose reduction. In the OLE at 1 and 1.5 years, the mean (SD) weight gain was 1.1 (5.9) kg and 0.5 (7.1) kg, respectively. SAEs were reported in 33 (12%) patients, 6 patients (2.2%) reported treatment-related SAEs. One SAE led to death (sudden unexpected death in epilepsy, considered not treatment related). The MPC was –83.4% at 18 months in the OLE vs DBP baseline. Updated safety and efficacy analyses will be presented.
XEN1101 was generally well tolerated and demonstrated an OLE safety profile similar to that seen in the DBP and other antiseizure medications used in FOS treatment. No new safety signals emerged. These promising data suggest long-term efficacy of XEN1101 in a difficult-to-treat population.
Authors/Disclosures
Jacqueline French, MD, FAAN (NYU Comprehensive Epilepsy Ctr)
PRESENTER 		Dr. French has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Epilepsy Foundation. The institution of Dr. French has received research support from Epilepsy Study Consortium/ Epilepsy Foundation (Funded by UCB). The institution of Dr. French has received research support from GW/One8 Foundation/FACES. The institution of Dr. French has received research support from NINDS. The institution of Dr. French has received research support from Xenon. The institution of Dr. French has received research support from Cerevel. The institution of Dr. French has received research support from FACES. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Epilepsy Study Consortium. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Praxis. Dr. French has received personal compensation in the range of $50,000-$99,999 for serving as a Chief Medical/Innovation Officer with Epilepsy Foundation. Dr. French has a non-compensated relationship as a Consultant with Acadia Pharmaceuticals Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Access Industries that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Acuta Capital Partners LLC that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with AFASCI Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Agrithera, Inc. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Alkermes that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Alterity Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Angelini Pharma S.p.A. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Autifony Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Axonis Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bain Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Beacon Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biogen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biohaven Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Bloom Science, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bright Minds Biosciences, Inc. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Capsidia Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Cerebral Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerecin, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Cerevel that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, SAB with Cognizance Biomarkers that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Ceribell that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cowen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Crossject that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with EcoR1 Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with EG 427 that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant, Advisory Board with Eisai that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Encoded Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant/Advisory Board with Engrail that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epitel, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with EpiMinder that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Grin Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Harmony that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with Ionis Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with iQure Pharma, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with IQVIA that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Janssen Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Jazz Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Leal Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, with Livanova that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with London Research & Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Longboard Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Maplight Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Marinus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Medscape/Web MD that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Modulight Bio that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Montara Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Mosaica Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Neumarker that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Neumirna Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neurelis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, Advisory Board with Neurocrine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Neuropace that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with NeuroPro Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Neuroventis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Neurona Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, Advisory Board with Neuvarti that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Noema that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Ono Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, Advisory Board with Otsuka that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, Advisory Board with Ovid Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Praxis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with PureTech LYT Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with QurAlis Corp that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Rapport Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Receptor Holdings, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rivervest Venture Partners that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Sage Therapeutics, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with SK Life Science that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Stoke that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Stream Neuroscience that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Supernus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Takeda that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Taysha Gene Therapies that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with UCB, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with uniQure that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Ventus Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Vida Ventures Management that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Xenon Pharmaceuticals that is relevant to AAN interests or activities.
Roger J. Porter, MD, FAAN Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Xenon. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Longboard. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axonis. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bright MInds Bioscience. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Autobah. Dr. Porter has received publishing royalties from a publication relating to health care.
Emilio Perucca Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SKB Life Sciences. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon Pharma. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRIN Therapeutics. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sun Pharma. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Takeda. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Xenon Pharma. Emilio Perucca has received publishing royalties from a publication relating to health care. Emilio Perucca has received publishing royalties from a publication relating to health care.
Martin Brodie Martin Brodie has nothing to disclose.
Michael A. Rogawski, MD, PhD (University of California - Davis) Dr. Rogawski has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Xenon Pharmaceuticals.
Cynthia L. Harden, MD (Xenon Pharmaceuticals Inc) Dr. Harden has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc.. Dr. Harden has stock in Xenon Pharmaceuticals Inc.. Dr. Harden has received intellectual property interests from a discovery or technology relating to health care.
Jenny Qian Jenny Qian has nothing to disclose.
Constanza Luzon Constanza Luzon has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc.. Constanza Luzon has stock in Xenon Pharmaceuticals.
Christopher Kenney No disclosure on file
Gregory N. Beatch, PhD Dr. Beatch has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc. Dr. Beatch has stock in Xenon Pharmaceuticals Inc. Dr. Beatch has received intellectual property interests from a discovery or technology relating to health care.