VANCOUVER, British Columbia, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced the medical journal JAMA Neurology has published peer-reviewed efficacy and safety results from the X-TOLE Phase 2b randomized clinical trial of XEN1101, a novel potassium channel opener, in adults with focal epilepsy.

温哥华，不列颠哥伦比亚省，2023年10月9日（GLOBE NEWSWIRE）-Xenon Pharmaceuticals Inc.（纳斯达克股票代码：XENE），一家以神经病学为重点的生物制药公司，今天宣布医学期刊JAMA neurology已发表同行评审的疗效和安全性结果来自X-TOLE 2b期随机临床试验XEN1101，一种新型钾通道开放剂，用于成人局灶性癫痫。

Importantly, the efficacy and safety findings of this clinical trial supported the further clinical development in epilepsy of XEN1101, which is currently being evaluated in Phase 3 clinical trials in patients with focal onset seizures (FOS) and primary generalized tonic-clonic seizures. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “We are pleased to report that the peer-reviewed results from our Phase 2b X-TOLE study of XEN1101 in adults with focal epilepsy have been published in the prestigious JAMA Neurology journal.

重要的是，该临床试验的有效性和安全性结果支持了XEN1101癫痫的进一步临床开发，目前正在3期临床试验中对局灶性发作（FOS）和原发性全身性强直阵挛性发作的患者进行评估。氙总裁兼首席执行官伊恩·莫蒂默先生说：“我们很高兴地报告说，我们对XEN1101在成人局灶性癫痫患者中进行的2b期X-TOLE研究的同行评审结果已经发表在着名的JAMA神经病学杂志。

With a cohort of patients now on drug for more than four years as we continue to gather data from our ongoing open-label extension study, XEN1101 continues to demonstrate its efficacy through sustained seizure reduction and a compelling product profile with once-daily dosing with food and no titration required.

随着我们继续从正在进行的开放标签扩展研究中收集数据，一组患者现在正在服药超过四年，XEN1101继续通过持续减少癫痫发作和令人信服的产品概况证明其有效性，每日一次给予食物并且不需要滴定。

Based on the need for new, efficacious, and well-tolerated antiseizure medications, we continue to advance the Phase 3 development of XEN1101 in our X-TOLE2, X-TOLE3 studies (in focal onset seizures) and the X-ACKT study (in primary generalized tonic-clonic seizures). We look forward to presenting additional longer-term data from the X-TOLE open-label extension study at AES 2023, the upcoming annual meeting of the American Epilepsy Society in December.” In the XEN1101 Phase 2b X-TOLE study, the primary efficacy endpoint was the median per.

基于对新的，有效的和耐受性良好的抗癫痫药物的需求，我们继续推进XEN1101在我们的X-TOLE2，X-TOLE3研究（局灶性癫痫发作）和X-ACKT研究中的3期开发（在原发性全身强直-阵挛性癫痫发作中）。我们期待在12月即将召开的美国癫痫学会年会AES 2023上的X-TOLE开放标签扩展研究中提供更多的长期数据。”在XEN1101 2b期X-TOLE研究中，主要疗效终点是中位数per。