A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures - XPF-010-302

开始日期2023-10-13

申办/合作机构

Xenon Pharmaceuticals, Inc.

NCT05716100 / Recruiting临床3期

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

开始日期2023-05-09

申办/合作机构

Xenon Pharmaceuticals, Inc.

[+1]

NCT05718817 / Enrolling by invitation临床3期

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy

This study will evaluate the long term safety, tolerability, PK, and efficacy of XEN1101 25 mg QD taken orally in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 3 years.

开始日期2023-04-25

申办/合作机构

Xenon Pharmaceuticals, Inc.

[+1]

100 项与 Azetukalner 相关的临床结果

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100 项与 Azetukalner 相关的转化医学

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100 项与 Azetukalner 相关的专利（医药）

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项与 Azetukalner 相关的文献（医药）

2024-10-01·EPILEPSIA

Progress report on new medications for seizures and epilepsy: A summary of the 17th Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVII). II. Drugs in more advanced clinical development

Article

作者: White, H. Steve ; Johannessen, Svein I. ; Perucca, Emilio ; Tomson, Torbjörn ; Koepp, Matthias J. ; Bialer, Meir ; Perucca, Piero

Abstract:

The 17th Eilat Conference on New Antiepileptic Drugs and Devices took place in Madrid, Spain on May 5–8, 2024. As usual, the core part of the conference consisted of presentations on investigational drugs at various stages of development for epilepsy‐related indications. Summaries of information on compounds in preclinical or early clinical development are included in an accompanying publication (Part I). In this article, we provide summaries for five compounds in more advanced clinical development, i.e. compounds for which some information on antiseizure activity in individuals with epilepsy is available. These investigational treatments include azetukalner (XEN1101), a potent, KV7.2/7.3‐specific potassium channel opener in development for the treatment of focal seizures, generalized tonic–clonic seizures, and major depressive disorder; bexicaserin (LP352), a selective 5‐HT2C receptor superagonist in development for the treatment of seizures associated with developmental and epileptic encephalopathies; radiprodil, a selective negative allosteric modulator of NR2B subunit‐containing N‐methyl‐D‐aspartate glutamate receptors, in development for the treatment of seizures and behavior manifestations associated with disorders caused by gain‐of‐function mutations in the GRIN1, −2A, ‐2B, or ‐2D genes; soticlestat (TAK‐935), a selective inhibitor of cholesterol 24‐hydroxylase in development for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut syndrome; and STK‐001, an antisense oligonucleotide designed to upregulate Nav1.1 protein expression and improve outcomes in individuals with Dravet syndrome. The diversity in mechanisms of action of these agents illustrates different approaches being pursued in the discovery of novel treatments for seizures and epilepsy. For two of the compounds discussed in this report (azetukalner and soticlestat), clinical evidence of efficacy has already been obtained in a randomized placebo‐controlled adjunctive‐therapy trial. For the other compounds, adequately powered placebo‐controlled efficacy trials have not been completed to date.

2023-11-01·JAMA neurology

Efficacy and Safety of XEN1101, a Novel Potassium Channel Opener, in Adults With Focal Epilepsy

Article

Importance:

Many patients with focal epilepsy experience seizures despite treatment with currently available antiseizure medications (ASMs) and may benefit from novel therapeutics.

Objective:

To evaluate the efficacy and safety of XEN1101, a novel small-molecule selective Kv7.2/Kv7.3 potassium channel opener, in the treatment of focal-onset seizures (FOSs).

Design, Setting, and Participants:

This phase 2b, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging adjunctive trial investigated XEN1101 over an 8-week treatment period from January 30, 2019, to September 2, 2021, and included a 6-week safety follow-up. Adults experiencing 4 or more monthly FOSs while receiving stable treatment (1-3 ASMs) were enrolled at 97 sites in North America and Europe.

Interventions:

Patients were randomized 2:1:1:2 to receive XEN1101, 25, 20, or 10 mg, or placebo with food once daily for 8 weeks. Dosage titration was not used. On completion of the double-blind phase, patients were offered the option of entering an open-label extension (OLE). Patients not participating in the OLE had follow-up safety visits (1 and 6 weeks after the final dose).

Main Outcomes and Measures:

The primary efficacy end point was the median percent change from baseline in monthly FOS frequency. Treatment-emergent adverse events (TEAEs) were recorded and comprehensive laboratory assessments were made. Modified intention-to-treat analysis was conducted.

Results:

A total of 325 patients who were randomized and treated were included in the safety analysis; 285 completed the 8-week double-blind phase. In the 325 patients included, mean (SD) age was 40.8 (13.3) years, 168 (51.7%) were female, and 298 (91.7%) identified their race as White. Treatment with XEN1101 was associated with seizure reduction in a robust dose-response manner. The median (IQR) percent reduction from baseline in monthly FOS frequency was 52.8% (P &lt; .001 vs placebo; IQR, −80.4% to −16.9%) for 25 mg, 46.4% (P &lt; .001 vs placebo; IQR, −76.7% to −14.0%) for 20 mg, and 33.2% (P = .04 vs placebo; IQR, −61.8% to 0.0%) for 10 mg, compared with 18.2% (IQR, −37.3% to 7.0%) for placebo. XEN1101 was generally well tolerated and TEAEs were similar to those of commonly prescribed ASMs, and no TEAEs leading to death were reported.

Conclusions and Relevance:

The efficacy and safety findings of this clinical trial support the further clinical development of XEN1101 for the treatment of FOSs.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03796962

2023-08-01·Acta pharmacologica Sinica

Functional characterization and in vitro pharmacological rescue of KCNQ2 pore mutations associated with epileptic encephalopathy.

Article

作者: Li, Ping ; Tian, Fu-Yun ; Yang, Chuan-Yan ; Shen, Yan-Wen ; Yang, Gui-Mei ; Gao, Zhao-Bing ; Yuan, Hui

Mutations in the KCNQ2 gene encoding K_V7.2 subunit that mediates neuronal M-current cause a severe form of developmental and epileptic encephalopathy (DEE). Electrophysiological evaluation of KCNQ2 mutations has been proved clinically useful in improving outcome prediction and choosing rational anti-seizure medications (ASMs). In this study we described the clinical characteristics, electrophysiological phenotypes and the in vitro response to KCNQ openers of five KCNQ2 pore mutations (V250A, N258Y, H260P, A265T and G290S) from seven patients diagnosed with KCNQ2-DEE. The KCNQ2 variants were transfected into Chinese hamster ovary (CHO) cells alone, in combination with KCNQ3 (1:1) or with wild-type KCNQ2 (KCNQ2-WT) and KCNQ3 in a ratio of 1:1:2, respectively. Their expression and electrophysiological function were assessed. When transfected alone or in combination with KCNQ3, none of these mutations affected the membrane expression of KCNQ2, but most failed to induce a potassium current except A265T, in which trace currents were observed when co-transfected with KCNQ3. When co-expressed with KCNQ2-WT and KCNQ3 (1:1:2), the currents at 0 mV of these mutations were decreased by 30%-70% compared to the KCNQ2/3 channel, which could be significantly rescued by applying KCNQ openers including the approved antiepileptic drug retigabine (RTG, 10 μM), as well as two candidates subjected to clinical trials, pynegabine (HN37, 1 μM) and XEN1101 (1 μM). These newly identified pathologic variants enrich the KCNQ2-DEE mutation hotspots in the pore-forming domain. This electrophysiological study provides a rational basis for personalized therapy with KCNQ openers in DEE patients carrying loss-of-function (LOF) mutations in KCNQ2.

项与 Azetukalner 相关的新闻（医药）

2024-11-04

·生物制药小编

癫痫药物的春天来了？

癫痫治疗领域再次迎来重磅交易。近日，灵北制药宣布以26亿美元的价格，收购Longboard Pharmaceuticals。后者的核心管线是bexicaserin，一款高选择性的5-HT2C超级激动剂，用于治疗难治性癫痫DEE，已完成二期临床并获得突破疗法认证。收购消息传出后，Longboard股价大涨超50%。年初至今，由于公布bexicaserin 1b/2a期研究的积极顶线数据，其股价一路上涨，涨幅超过888%。灵北制药是丹麦精神疾病与神经系统疾病领域先驱，也是为数不多专注于CNS疾病的制药公司之一。大手笔收购Longboard，也意味着其在神经学和罕见疾病这片充满挑战却又极具潜力的领域中，更进一步。尽管失败如影随形，但是，随着越来越多药企尝试征服这一CNS研发高地，或许，正如阿尔兹海默症般，经历数十载漫长黑夜，癫痫药物的开发正在迎来春天。严重未满足的临床需求癫痫是最常见的中枢神经系统疾病（CNS）之一，影响着全球5000多万人。作为一种高致残性的慢性神经系统疾病，癫痫以其发作的不可预测性对患者生活造成极大影响。对于患者来说，治疗首选方案是抗癫痫发作药物（ASMs），这也是最基础、最重要的治疗手段。过去几十年，已有超过20种ASMs问世，从第一代演变至第三代，然而，疗效有限、副作用明显等问题依然影响着癫痫患者的治疗效果，是目前ASMs亟待解决的问题。比如，第一代ASMs包括苯巴比妥、苯妥英钠、卡马西平、丙戊酸、氯硝西泮等。这些药物在早期的癫痫治疗中发挥了重要作用，但其副作用较为明显，如嗜睡、头晕、恶心等，并且药物之间的相互作用较多，需要严格控制剂量和监测不良反应。而第二代ASMs如加巴喷丁、拉莫三嗪、托吡酯、左乙拉西坦、普瑞巴林等。相比第一代药物，副作用有所减少，药物间的相互作用也较少，是目前治疗的主流。但是，在过去的30年中，二代ASMs的广泛使用似乎并未使癫痫药物治疗的整体疗效和耐受性得到提高。近几年上市的三代ASMs，能否打破目前的停滞状态还有待于进一步观察。与之相比，还有一类患者的治疗困境尤为突出。尽管WHO指出70%的癫痫患者通过ASMs治疗可达到消除癫痫发作，但仍有约30%的患者对现有ASMs不敏感，癫痫发作无法得到有效控制，称为难治性癫痫。这类患者由于异质性、耐药性导致可选择的药物十分匮乏。典型如全球神经系统疾病负担的第三大元凶——DEEs。这也是灵北制药此次收购布局的领域。 DEEs是一组罕见的神经系统疾病，通常在婴儿期发作，具有难治性癫痫发作和发育迟缓和/或倒退的特征。同时DEEs涵盖了超过25种不同的综合征，包括Dravet综合征（DS）、Lennox-Gastaut综合征（LGS）、结节性硬化症（TSC）、CDKL5缺乏症（CDD）等，其中仅有4种有获批药物。虽然这些综合征单独被认为是孤儿病，但据估计在美国大约有22万患者受到DEEs综合征的影响。作为一组疾病，其总体发病率达到（0.27～0.54）/1000例新生儿，癫痫发作的影响还伴随到他们的儿童、成年时期，甚至可能导致过早死亡或者避免死亡但留下严重的神经系统残疾。而在治疗方面，大多数DEE患者采用多种药物联合治疗，并随时间更换药物。然而，几乎所有患者都经历了多次癫痫发作和治疗相关的副作用。换句话说，DEEs治疗领域存在严重未满足的临床需求，需要更多更好的治疗选择。潜在破局者bexicaserin 灵北制药此次收购Longboard，看中的就是bexicaserin有成为DEEs领域破局者的潜力。 Bexicaserin是由Longboard研发的新型口服、高选择性、中枢作用的5-HT2C超级激动剂，正在开发用于治疗与DEE相关的癫痫发作，例如Dravet综合征、Lennox-Gastaut综合征、结节性硬化症、CDKL5缺乏症和其他癫痫性疾病。 5-HT是一种重要的脑内神经递质，与神经元的兴奋-抑制平衡密切相关，其受体包含多种亚型。其中5-HT2C受体，是一种G蛋白偶联受体，这也是Longboard一直专注的成药靶点，已被确定为治疗肥胖和其他CNS疾病(如精神分裂症和药物成瘾)的有效药物靶点。但是，由于5-HT2C受体与其他两个5-HT2亚型(5-HT2A和5-HT2B)具有约50%的序列相似性，因此导致大量药物存在脱靶效应，或因选择性差从而与5-HT2A、5-HT2B结合，产生幻觉和心脏瓣膜病等副作用。比如2020年获批用于治疗Dravet综合征的5-HT2激动剂Fintepla，其药物标签上有一个黑框警告，该药物的活性成分与瓣膜性心脏病和肺动脉高压的风险有关。因此，开发高选择性5-HT2C受体激动剂，作为潜在治疗DEEs药物更具前景。临床前试验已经验证了bexicaserin的5-HT2C受体高选择性以及相比内源性5-HT能诱导更强的细胞反应。与Fintepla相比，bexicaserin对5-HT2C受体的选择性增加，从而减少了与5-HT2A和5-HT2B激动剂相关的潜在不良反应的可能性。今年1月，Longboard公布了bexicaserin 1b/2a期研究的积极顶线数据，结果显示：在主要疗效终点方面，在DEE研究人群中，bexicaserin使可数运动性癫痫发作的中位数减少53.3%，远高于安慰剂组的20.8%。另外，Longboard还公布了在DS、LGS和其他DEE亚组中的数据，癫痫发作的中位数降低分别为72.1%、48.1%和61.2%。这一数据，与此前Fintepla治疗DS的三期临床数据不相上下。而在安全性方面，bexicaserin表现似乎更优。此前Fintepla各组患者经历了至少一次严重TEAE，bexicaserin最常见的不良事件则是嗜睡、食欲下降、便秘、腹泻和嗜睡。数据公布后，Longboard的股价一路上涨，截至收购消息公布前，涨幅已经接近600%，而年初至今，其股价涨幅超过888%。 7月，bexicaserin获得FDA突破性疗法认定，用于2岁以上DEEs患者的治疗。9月以来，Longboard正式开启了bexicaserin针对DS的Ⅲ期试验。优秀的临床表现也成功吸引了灵北制药入局，并对其报以厚望，计划在2028年第四季度正式推出，预计bexicaserin全球销售额达到15-20亿美元。灵北制药总裁Charl van Zyl表示，此次收购是“变革型的交易”，将成为灵北神经罕见病的基石，有可能推动未来十年的发展。癫痫药物的春天来了？由于血脑屏障阻碍、致病机制不明、缺乏有效疾病模型等原因，包括癫痫在内的CNS疾病新药研发困难重重。幸运的是，包括Longboard在内的biotech在不断努力，包括灵北制药、艾伯维、武田等大药企的加入，也在不断增强我们对于征服该领域的信心。去年底，艾伯维宣布以87亿美元收购Cerevel，后者管线较多，其中之一包括Darigabat，用于治疗难治性癫痫和恐慌症，已经进入2期临床。整体来看，除了前文提及的bexicaserin、Fintepla，还有一些已上市以及很多处于研究中的新型抗癫痫药物。根据DelveInsight公司提供的数据，目前有超过75家药企在开发癫痫药物，在研药物超过90个。可以说，这些新一代ASMs的研究和开发为癫痫患者提供了更多治疗选择。而去年以来，癫痫领域在基础、临床研究方面取得了诸多进展。比如加拿大药企Xenon，其核心管线XEN1101是一款新型小分子Kv7.2/Kv7.3钾通道开放剂，主要开发适应症是癫痫和抑郁症。 Kv7.2/Kv7.3电压门控钾通道在大脑神经元轴突周围和轴突上的表达，是一个特别有吸引力的靶点。这些抑制性离子通道在靠近动作电位阈值的神经膜去极化对抗癫痫的过度兴奋起着制约作用，增强Kv7.2/Kv7.3通道开放的药物已被证明能减少癫痫发作。2011年，瑞替加滨被FDA批准为治疗癫痫的抗惊厥药物，但由于存在严重的皮肤及视网膜色素沉积等毒副作用，已经退市。与之相比，XEN1101有更高的体外和体内活性，瑞替加滨需要每天给药三次，而XEN1101每天给药一次，且没有色素沉积等问题。临床二期数据显示，XEN1101高剂量组癫痫发作频率相比基线降低52.8%，而安慰剂组只有18.2%。国内方面，上海药物所研发的派恩加滨同样瞄准这一靶点。而与瑞替加滨相比，派恩加滨的化学性质、活性、药代和安全性特征均显著优化，没有色素沉积风险。临床一期试验证明其具有良好的安全和代谢特性，目前出于二期阶段。再比如，Epidiolex是一种首创运用大麻成分的抗癫痫疗法，也是首个获批用于DS的药物，其主要成分大麻二酚（CBD）是一种多靶点分子，被证实具有明显抗癫痫活性。不过，CBD抗癫痫作用的分子机制仍不清楚，其可能的治疗靶点包括离子通道、转运体和跨膜信号蛋白，具体抗癫痫作用的机制仍有待研究。而最新研究显示，LPI-GPR55信号传导通路是CBD抗癫痫靶点的潜在调节因子，在联合用药方面，CBD也为对GABAAR调节剂（例如苯二氮卓类药物）无效的难治性癫痫患者提供了一种潜在的治疗选择。而在新机制研究方面，武田制药8.65亿美元收购而来的胆固醇24羟化酶（CH24H）抑制剂soticlestat，属于一个全新的抗癫痫作用机制，是通过抑制CH24H活性，减少胆固醇转化为24S-羟基胆固醇，从而降低谷氨酸能通路的兴奋性，减少癫痫发作。积极的二期试验结果为DS和LGS患者提供了新的药物选择的可能性，尤其是那些对现有药物不敏感的患者。然而，三期试验双双折戟。总体来看，目前在研治疗方法主要针对遗传学、离子通道和其他神经递质，以及其他潜在性FIC干预措施，比如干细胞、肠道微生物组、AAV9基因疗法等在进行早期研究，也为患者带来了更多新希望。从趋势来看，癫痫新疗法的研究不再局限于发作的控制，而是包括从发病机制的根源上改变癫痫发作的治疗及预后情况。总结需要承认的是，尽管新的突破每天都有可能发生，但这尚无法彻底改变CNS疾病新药研发的困境。就在上半年，一些药企在研癫痫新药遭遇失败。4月份，Addex宣布ADX71149在治疗对左乙拉西坦或布瓦西坦反应不佳的局灶性癫痫发作的2期研究失败；6月份，Marinus公司口服抗癫痫药物Ztalmy的静脉制剂ganaxolone治疗难治性癫痫持续状态开展的试验失败；武田的soticlestat，在治疗LGS及DS这两种难治性癫痫综合征的三期试验均未达主要终点；对此，武田表示，在16周的治疗中，治疗应答率、护理人员和临床医生对病情改善的总体印象以及癫痫发作强度和持续时间尺度都发生了显著变化。总体数据呈积极趋势，希望与监管机构商讨下一步行动。在号称“研发黑洞”的CNS领域，也的确需要武田这种屡败屡战的精神。期待新的革命性突破，早日到来。

并购临床2期

2024-10-02

·BioSpace

Xenon to Present at BofA Securities 2024 CNS Therapeutics Virtual Conference

VANCOUVER, British Columbia and BOSTON, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today announced its participation in the upcoming BofA Securities 2024 CNS Therapeutics Virtual Conference taking place October 7, 2024. Fireside Chat Presentation Details: Date: Monday, October 7, 2024 Time: 11:40 am Eastern Time Webcast: Register here A live webcast of the company presentation will be available on the “ Investors ” section of Xenon’s website and posted for replay following the event. The above listed dates and times are subject to change. About Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals (Nasdaq:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are advancing a novel product pipeline to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, our lead Kv7 channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. For more information, please visit . “Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner. Contacts: For Investors: Chad Fugere Vice President, Investor Relations (857) 675-7275 investors@xenon-pharma.com For Media: Colleen Alabiso Senior Vice President, Corporate Affairs (617) 671-9238 media@xenon-pharma.com

2024-09-09

·GlobeNewswire-Health Care

Xenon Showcases Azetukalner Data at 15th European Epilepsy Congress

Three presentations highlighting long-term data and improved quality of life outcomes in adults with focal onset seizures VANCOUVER, British Columbia and BOSTON, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today announced three poster presentations at the 15th European Epilepsy Congress (EEC) taking place in Rome, Italy. Azetukalner, a novel, potent Kv7 channel opener, is the most advanced, clinically validated potassium channel modulator in late-stage development for multiple indications, including focal onset seizures (FOS), primary generalized tonic-clonic seizures (PGTCS) and major depressive disorder (MDD). “We are excited for this opportunity to engage with leading epileptologists at EEC in Rome and share long-term azetukalner data from our ongoing X-TOLE open-label extension study. Azetukalner represents the only Kv7 potassium channel opener in clinical development that is supported by Phase 2b data as well as long-term efficacy and safety data in epilepsy patients,” stated Dr. Christopher Kenney, Chief Medical Officer of Xenon. “These data are particularly impressive given the baseline disease severity, with patients who are out to 30 months in the open-label extension study showing a greater than 90% reduction in median monthly seizure frequency, while approximately one in four patients on azetukalner for at least two years in the OLE have experienced a period of seizure freedom of a year or longer.” Dr. Kenney continued, “We are also presenting patient-reported survey data illustrating the substantial burden of illness for people living with epilepsy, with reduced quality of life, high seizure frequency and fatigue, as well as other comorbidities such as anxiety and depression, further underscoring the need for new medications to help people living with epilepsy.” Presentations at EEC: Poster #P282: Azetukalner (XEN1101), a Novel, Potent Kv7 Potassium Channel Opener: Interim Data From an Ongoing, Long‑Term, Open‑Label Extension of a Phase 2b Study (X‑TOLE) in Adults With Focal Onset SeizuresPresenter: Jacqueline A. French, New York University Grossman School of Medicine and NYU Langone Health, New York, NYSession Times: Daily from 1:30-3:00 pm CEST Poster #P281: Long-term, Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Improvements in Adults With Focal Onset Seizures Treated With Azetukalner (XEN1101) in an Ongoing, Open-Label Extension of a Phase 2b study (X-TOLE)Presenter: Christian Brandt, Bethel Epilepsy Centre, Mara Hospital, University Hospital for Epileptology, Bielefeld, GermanySession Times: Daily from 1:30-3:00 pm CESTPoster Tour: S2 Clinical Neurophysiology/Drug Therapy Poster #P406: Non-seizure Symptoms, Mental Health Comorbidities, and Quality of Life in Patients Reporting Focal Onset SeizuresPresenter: Cynthia Harden, Xenon Pharmaceuticals Inc. Session Times: Daily from 1:30-3:00 pm CEST Posters will be available for viewing at the conference from Sunday, September 8 until Tuesday, September 10 at 4:00 pm CEST and will be added to the Xenon website consistent with conference guidelines. Xenon is also hosting a Scientific Exhibit at location SE1 and Booth #346. About Xenon Pharmaceuticals Inc.Xenon Pharmaceuticals (Nasdaq:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are advancing a novel product pipeline to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, our lead Kv7 channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. For more information, please visit www.xenon-pharma.com. About the Azetukalner Phase 3 Epilepsy ProgramXenon’s Phase 3 epilepsy program includes three ongoing Phase 3 clinical trials in focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS). Designed closely after the Phase 2b X-TOLE clinical trial, the Phase 3 X-TOLE clinical trials are multicenter, randomized, double-blind, placebo-controlled studies evaluating the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of azetukalner administered with food as adjunctive treatment in approximately 360 patients with FOS per study. The primary efficacy endpoint is the median percent change (MPC) in monthly seizure frequency from baseline through the double-blind period (DBP) of azetukalner compared to placebo. X-ACKT is a multicenter, randomized, double-blind, placebo-controlled study evaluating the clinical efficacy, safety, and tolerability of 25 mg of azetukalner administered with food as adjunctive treatment in approximately 160 patients with PGTCS. The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the DBP of azetukalner compared to placebo. Safe Harbor StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and potential results from clinical trials; the potential efficacy, safety profile, future development plans in current and anticipated indications, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in our azetukalner and other pipeline and development programs; and our ability to successfully develop and obtain regulatory approval of azetukalner and our other product candidates. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including azetukalner, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of market, industry, and regulatory conditions on clinical trial enrollment; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks identified in our filings with the U.S. Securities and Exchange Commission and the securities commissions in British Columbia, Alberta, and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. “Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner. Contacts: For Investors:Chad FugereVice President, Investor Relations(857) 675-7275investors@xenon-pharma.com For Media:Colleen AlabisoSenior Vice President, Corporate Affairs(617) 671-9238media@xenon-pharma.com

临床2期临床3期

100 项与 Azetukalner 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
强直阵挛性癫痫	临床3期	美国	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	阿根廷	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	澳大利亚	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	奥地利	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	保加利亚	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	加拿大	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	克罗地亚	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	捷克	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	德国	Xenon Pharmaceuticals, Inc.	2023-02-14
强直阵挛性癫痫	临床3期	以色列	Xenon Pharmaceuticals, Inc.	2023-02-14

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03796962 (X-TOLE, CTgov)	临床2期	癫痫部分性发作 \| 癫痫发作	325	XEN1101 (25 mg XEN1101)	鹹蓋簾繭積鹽範廠繭蓋(鬱齋鏇夢簾淵繭獵築蓋) = 觸憲夢壓簾廠窪鏇鏇齋製鬱積齋選廠遞窪遞鹹 (鏇積選鹹醖壓齋齋鬱蓋, 鑰淵積憲淵衊鹹餘窪衊 ~ 遞築網網鏇夢築網衊構) 更多	-	2024-09-24
				XEN1101 (20 mg XEN1101)	鹹蓋簾繭積鹽範廠繭蓋(鬱齋鏇夢簾淵繭獵築蓋) = 網壓繭窪願餘醖築顧構製鬱積齋選廠遞窪遞鹹 (鏇積選鹹醖壓齋齋鬱蓋, 餘觸獵鹹窪壓窪憲膚艱 ~ 構憲簾壓觸範艱蓋襯遞) 更多
NCT05376150 (X-NOVA, Company_Website) 人工标引	临床2期	重度抑郁症	168	Azetukalner 10mg	觸鬱鏇築觸鏇夢夢選鏇(觸壓範窪構糧齋糧糧憲) = 蓋鏇壓鏇鹽築獵蓋製蓋獵艱鬱遞鬱壓壓壓襯襯 (觸選鹹築觸顧醖憲構積 )	积极	2024-05-28
				Azetukalner 20mg	觸鬱鏇築觸鏇夢夢選鏇(觸壓範窪構糧齋糧糧憲) = 淵齋艱壓衊鑰觸鹹壓網獵艱鬱遞鬱壓壓壓襯襯 (觸選鹹築觸顧醖憲構積 ) 更多
S19.005 (AAN2024)	临床2期	癫痫部分性发作	285	XEN1101 10mg QD	餘廠選築鬱衊繭淵構窪(壓壓選醖壓壓壓鏇構廠) = -83.4% at 18 months in the OLE vs DBP baseline 鑰鑰淵積簾遞蓋餘衊鏇 (膚廠構網糧蓋顧鹽壓夢 ) 更多	积极	2024-04-09
				XEN1101 20mg QD
AAN2024	N/A	癫痫部分性发作	-	XEN1101 25mg	觸淵蓋襯築製鹹窪獵構(蓋範選鑰憲築齋願製選) = 齋艱衊艱範鏇繭積廠遞齋艱鑰淵構簾顧遞鹹鬱 (鑰蓋齋鹽築選獵簾製餘 )	-	2024-04-09
				Placebo	觸淵蓋襯築製鹹窪獵構(蓋範選鑰憲築齋願製選) = 鹹願餘獵膚積鏇範選淵齋艱鑰淵構簾顧遞鹹鬱 (鑰蓋齋鹽築選獵簾製餘 )
NCT03796962 (X-TOLE, AES2023) 人工标引	临床2期	癫痫部分性发作	170	XEN1101 (overall)	夢鹹餘鑰願鬱餘齋夢積(夢齋鹽壓壓鬱廠憲構遞) = 獵衊淵糧獵願選艱鹽鬱鏇網鹹獵壓鏇窪廠憲願 (憲醖構鹽範鏇製壓鑰積 ) 更多	积极	2023-12-03
				XEN1101 (seizure-free group)	夢鹹餘鑰願鬱餘齋夢積(夢齋鹽壓壓鬱廠憲構遞) = 夢遞鬱遞鬱憲襯蓋鬱範鏇網鹹獵壓鏇窪廠憲願 (憲醖構鹽範鏇製壓鑰積 ) 更多
NCT03796962 (X-TOLE, AES2023) 人工标引	临床2期	癫痫部分性发作	325	XEN1101	鏇壓淵憲膚壓構積獵艱(鏇鏇構醖簾顧鹹淵膚襯) = 獵製蓋觸廠構鹹鹹齋憲餘衊壓願膚範顧齋鹽膚 (獵夢糧鏇繭衊願簾繭鬱 )	积极	2023-12-03
				Placebo	鏇壓淵憲膚壓構積獵艱(鏇鏇構醖簾顧鹹淵膚襯) = 憲鏇齋憲廠鹹齋壓鏇窪餘衊壓願膚範顧齋鹽膚 (獵夢糧鏇繭衊願簾繭鬱 )
NCT03796962 (X-TOLE, AES2023) 人工标引	临床2期	癫痫部分性发作	275	XEN1101	餘鹽襯夢鹽範餘構蓋鑰(壓簾構繭淵餘淵鑰淵醖) = The most common reasons for discontinuation were lack of efficacy (13.1%), adverse events (12.0%), and study withdrawal by patient (11.3%). 鏇衊蓋顧糧顧糧繭齋壓 (壓築網淵鹹衊淵獵鹽糧 ) 更多	积极	2023-12-02
NCT05376150 (X-NOVA, Corporate Publications) 人工标引	临床2期	重度抑郁症	168	XEN1101 10 mg	淵壓艱膚選簾鏇網網淵(齋憲壓繭鏇範鑰範廠糧) = 簾願齋餘觸築窪鏇願齋網積齋願觸顧遞獵築餘 (餘鹹獵糧憲網淵艱範齋 )	积极	2023-11-27
				XEN1101 20 mg	淵壓艱膚選簾鏇網網淵(齋憲壓繭鏇範鑰範廠糧) = 製獵醖築齋蓋壓網製餘網積齋願觸顧遞獵築餘 (餘鹹獵糧憲網淵艱範齋 ) 更多
NCT03796962 (X-TOLE, Pubmed) 人工标引	临床2期	癫痫部分性发作	325	XEN1101 25 mg	鏇蓋鑰願獵築築窪顧膚(構艱顧繭鑰網醖衊廠願) = 壓範糧憲膚網簾網窪獵壓觸構製餘鹹艱獵襯鑰 (壓鑰衊糧鹹衊範艱獵構, -80.4 ~ -16.9)	积极	2023-10-09
				XEN1101 20 mg	鏇蓋鑰願獵築築窪顧膚(構艱顧繭鑰網醖衊廠願) = 鏇夢鹽膚淵顧鑰壓觸廠壓觸構製餘鹹艱獵襯鑰 (壓鑰衊糧鹹衊範艱獵構, -76.7 ~ -14.0)
IEC2023	临床2期	癫痫部分性发作	275	XEN1101 20 mg QD	獵範顧鬱淵窪蓋壓鏇艱(網壓鹹醖憲鬱選襯淵構) = 11.6% 夢壓夢願齋夢夢夢鏇襯 (憲壓鹹齋蓋艱構蓋繭夢 ) 更多	积极	2023-09-04
				Placebo