New experimental epilepsy drug reduces the frequency of seizures

Embargoed until: Publicly released: 2023-10-10 02:00

Australia; International; VIC

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A new drug being trialled for people with epilepsy helps reduce the most common type of seizures, known as focal-onset seizures, even in people already using currently available antiseizure medications. The phase 2 trial compared a range of doses of the drug, called XEN1101, with placebo in around 300 people. It found that reduction in monthly seizure frequency was 52.8% for people taking the highest dose (25mg) compared with 18.2% for placebo. The authors say the findings of this study suggest that the drug has the potential to help patients with focal-onset seizures and that the drug should continue to be developed as a treatment for focal-onset seizures.

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conference: JAMA Neurology

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Organisation/s: The University of Melbourne, Monash University, NYU Comprehensive Epilepsy Center

Funder: Dr French reported receiving salary support from the Epilepsy Foundation and for consulting work and/or attending scientific advisory boards on behalf of the Epilepsy Study Consortium during the conduct of the study; New York University salary support from Aeonian/Aeovian, Agrithera Inc, Alterity, Anavex, Angelini Pharma SPA, Arkin Holdings, Arvelle Therapeutics Inc, Athenen Therapeutics/Carnot Pharma, Autifony Therapeutics Ltd, Baergic Bio, Beacon Biosignals, Bioge, Biohaven Pharmaceuticals, Biomarin Pharmaceuticals, BioXcel, Bloom Science Inc, BridgeBio Pharma Inc, Camp4 Therapeutics, Cerebral Therapeutics, Cerevel, Clinical Education Alliance, Coda Biotherapeutics, Cognizance Biomarkers, Corlieve Therapeutics Crossject, Eisai, Eliem Therapeutics, Encoded Therapeutics, Engage Therapeutics, Engrail, Epalex, Epihunter, Epiminder, Epitel, Equilibre Biopharmaceuticals, Genentech Inc, Greenwich Biosciences, Grin Therapeutics, GW Pharma, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Knopp Biosciences, Korro Bio Inc, Lipocine, LivaNova, Longboard Pharmaceuticals, Lundbeck, Marinus, Merck, Modulight Bio, Neucyte Inc, Neumirna Therapeutics, Neurelis, Neurocrine, Neuroelectrics USA Corp Neuronetics Inc, Neuropace, NeuroPro Therapeutics, NxGen Medicine Inc, Ono Pharmaceutical Co, Otsuka, Ovid Therapeutics Inc, Paladin Labs Inc, Passage Bio, Pfizer, Praxis, Puretech LTY Inc, Rafa Laboratories Ltd, Rapport Therapeutics Inc, Receptor Holdings Inc, Sage Therapeutics Inc, SK Life Sciences, Sofinnova, Stoke, Supernus, Synergia Medical, Takeda, Third Rock Ventures LLC, UCB Inc, Ventus Therapeutics, Vida Ventures Management, Xeris, Zogenix, and Zynerba, and grants from Eisai, Engage Therapeutics, Equilibre, Jazz Pharmaceuticals, Lundbeck, Neurelis, Pfizer, SK Life Table 3. Summary of Adverse Eventsa (continued) Variable Treatment groupb Placebo (n = 114) XEN1101, 10 mg (n = 46) XEN1101, 20 mg (n = 51) XEN1101, 25 mg (n = 114) XEN1101, any dose (n = 211) Metabolism and nutrition disorders 0 1 (2.2) 0 0 1 (0.5) Hyponatremia 0 1 (2.2) 0 0 1 (0.5) Infections and infestations 1 (0.9) 0 0 0 0 Coronavirus infection 1 (0.9) 0 0 0 0 Injury, poisoning and procedural complications 1 (0.9) 0 0 0 0 Pneumothorax traumatic 1 (0.9) 0 0 0 0 Rib fracture 1 (0.9) 0 0 0 0 Abbreviation: TEAEs, treatment-emergent adverse events. a The TEAEs listed here are only the most common ones (5%in any arm). Because not all TEAEs in each cohort occurred at this level, the sum may not equal the total. b All doses were administered with food. Efficacy and Safety of XEN1101 in Adults With Focal Epilepsy Original Investigation Research jamaneurology.com (Reprinted) JAMA Neurology Published online October 9, 2023 E9 Confidential: Embargoed Until 11:00 am ET, October 09, 2023. Do Not Distribute Science, and UCB. She receives no personal income from these activities. Dr Porter received Xenon Pharmaceutical consultant fees during the conduct of this study. Dr Porter has also consulted with Ethicann, Longboard, Neurocrine and Axonis Pharmaceutical companies in the recent past. Dr Perucca reported receiving personal fees from Xenon Pharmaceuticals Inc during the conduct of the study, and personal fees from Angelini, Arvelle, Biogen, Eisai, GWPharma, Janssen, PMI Life Sciences, Sanofi, Shackelford Pharma, SK Life Science, Sun Pharma, Takeda, UCB Pharma, and Zogenix outside the submitted work. Dr Rogawski reported receiving personal fees from Xenon Pharmaceuticals during the conduct of the study, and personal fees from Aquestive Therapeutics, Brii Biosciences, Greenwich Biosciences, Marinus Pharmaceuticals, Merck Sharp & Dohme, PureTech Health, and SK Life Sciences outside the submitted work. Dr Pimstone reported being a full-time Xenon employee during the conduct of the study. Dr Aycardi reported being a full-time Xenon employee during the conduct of the study. Dr Harden reported being a Xenon Pharmaceuticals employee and shareholder during the conduct of the study; in addition, Dr Harden had a patent for US 17/093,183 pending and a patent for US 17/ 121,305 pending. Ms Qian reported being a full-time Xenon Pharmaceuticals employee and shareholder during the conduct of the study. Dr Luzon Rosenblut reported being a full time employee and shareholder of Xenon Pharmaceuticals during the conduct of the study. Dr Kenney reported being a full-time employee of Xenon Pharmaceuticals and shareholder. Dr Beatch reported holding a patent for XEN1101 pending as inventor, assigned to his employer; and is an employee and shareholder of Xenon Pharmaceuticals, the owner and developer of XEN1101 for epilepsy, which is the focus of the study being reported herein. No other disclosures were reported

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