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Abstract Details

The Impact of Disease Severity on Responder Rates in a Phase 2b Study of XEN1101, a Potent, Selective Potassium Channel Opener, in Adults with Focal Epilepsy (X-TOLE)
Epilepsy/Clinical Neurophysiology (EEG)
S19 - Epilepsy Clinical Trials and Long-term Studies (4:06 PM-4:18 PM)
004
To report the impact of baseline disease severity on the percentage of patients achieving a ≥50% reduction in seizure frequency (RR50) in the double-blind period (DBP) of a phase 2b study (X-TOLE) of XEN1101 in adults with focal onset seizures (FOS).
In the DBP, XEN1101 showed a significant, dose-dependent, and rapid-onset reduction in FOS frequency in adults with a median of 13.5 seizures/month and 6 tried and stopped antiseizure medications (ASMs) at baseline. 50.5% were taking 3 concomitant ASMs. A post hoc analysis suggested that the efficacy of XEN1101, measured by the median percentage change (MPC) in monthly FOS frequency, may be most pronounced in patients with less-severe disease. We report the potential impact of baseline disease severity on the RR50, another widely used endpoint for evaluating ASMs.
Patients (n=325) received 25, 20, or 10 mg XEN1101 or placebo in a 2:1:1:2 ratio, QD with food, with no titration required. Post hoc analyses assessed the influence of baseline disease severity (seizure frequency, number of concomitant ASMs, and number of previously tried ASMs) on the RR50 in FOS frequency through the 8-week DBP. 
RR50 was achieved by 14.9% of placebo (n=114) and 54.5% of XEN1101 25-mg (n=112) patients. With XEN1101 25-mg treatment, RR50 was achieved by 65.5% of patients with ≤8.5 seizures/month  (n=29) and 50.6% with >8.5 seizures/month (n=83) at baseline, 64.2% of patients with ≤6 prior ASMs (n=67) and 40.0% with >6 ASMs (n=45), and 56.9% of patients with 1–2 concomitant ASMs (n=58) and 51.9% with 3 concomitant ASMs (n=54).
Consistent with the significant MPC seizure reduction, 54.5% of patients in the 25-mg XEN1101 group achieved RR50. XEN1101 was relatively more effective in patients with indicators of less-severe disease. XEN1101 may be appropriate for patients with focal epilepsy across the spectrum of disease severity. 
Authors/Disclosures
Roger J. Porter, MD, FAAN
PRESENTER 		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.
Jacqueline French, MD, FAAN (NYU Comprehensive Epilepsy Ctr) 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 $100,000-$499,999 for serving as a Chief Medical/Innovation Officer with Epilepsy Foundation. Dr. French has a non-compensated relationship as a Consultant with Angelini 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 with Bright minds Biosciences 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 with Cognizance Biomarkers that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Arvelle that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Beacon biosignals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biohaven Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bloom Science Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant, scientific advisory board with Camp4 Therapeutics Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Scientific Advisory Board with Cerebral Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerevel that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Coda Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Genentech Inc 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 Consultant with Eisai, that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Eliem Therapeutics 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 with iQure Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Engrail that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epihunter that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epiminder 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 Equilibre BioPharmaceuticals 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 GW Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Janssen Pharmaceutica that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Jazz Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Knopp Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Lipocine 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 with Longboard Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Lundbeck that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Marinus 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,SAB with Neumirna Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant,SAB with Neurocrine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuroelectrics USA Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuronetics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ono Pharmaceutical Co that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Otsuka Pharmaceutical Development that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Ovid Therapeutics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Paladin Labs Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rapport Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Praxis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with PureTech LTY Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with SK Life Sciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Stoke 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, SAB with UCB Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ventus Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, steering committee with Xenon that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Korro Bio Inc 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 Advisory board with Receptor that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Sage Therpeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with Third Rock Ventures 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 Consulting with Pfizer that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Agrithera, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting with Autifony therapeutics, Unlimited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Baergic Bio that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Biogen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Biomarin Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Axonis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Capsida Biotherapeutics 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 that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Afaci that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ceribell that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Clinical 好色先生 Alliance that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with EcoR1 Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cowen and Company LLC that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epalex that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Iqvia RDS that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Leal Therapeutics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neurona Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuroventis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neurvati 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 Consultant with Harmony/Epigenyx 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 Noema that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rafa Laboratories 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 with Taysha Gene Therapies 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.
Emilio Perucca Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sintetica. 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.
Martin Brodie Martin Brodie has nothing to disclose.
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.
Constanza Luzon Constanza Luzon has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc.. Constanza Luzon has stock in Xenon Pharmaceuticals.
Jenny Qian Jenny Qian has nothing to disclose.
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.