Xenon Showcases Azetukalner Data at 15th European Epilepsy Congress
Xenon Pharmaceuticals (Nasdaq:XENE) presented three posters at the 15th European Epilepsy Congress showcasing long-term data for azetukalner, a novel Kv7 channel opener, in treating focal onset seizures (FOS). Key highlights include:
1. Patients in the X-TOLE open-label extension study showed >90% reduction in median monthly seizure frequency after 30 months.
2. Approximately 25% of patients on azetukalner for ≥2 years experienced ≥1 year of seizure freedom.
3. Quality of life improvements were reported in adults with FOS treated with azetukalner.
4. Xenon is conducting three Phase 3 trials for azetukalner in FOS and primary generalized tonic-clonic seizures (PGTCS).
Xenon Pharmaceuticals (Nasdaq:XENE) ha presentato tre poster al 15° Congresso Europeo sull'Epilessia, mostrando dati a lungo termine per azetukalner, un nuovo apritore del canale Kv7, nel trattamento delle crisi focali (FOS). I punti salienti includono:
1. I pazienti nello studio di estensione open-label X-TOLE hanno mostrato una riduzione di oltre il 90% nella frequenza mensile mediana delle crisi dopo 30 mesi.
2. Circa il 25% dei pazienti trattati con azetukalner per ≥2 anni ha sperimentato ≥1 anno di libertà da crisi.
3. Sono stati riportati miglioramenti nella qualità della vita negli adulti con FOS trattati con azetukalner.
4. Xenon sta conducendo tre studi di Fase 3 per azetukalner in FOS e nelle crisi tonico-cloniche primarie generalizzate (PGTCS).
Xenon Pharmaceuticals (Nasdaq:XENE) presentó tres carteles en el 15° Congreso Europeo de Epilepsia, mostrando datos a largo plazo para azetukalner, un nuevo abridor del canal Kv7, en el tratamiento de las crisis de inicio focal (FOS). Los puntos destacados incluyen:
1. Los pacientes en el estudio de extensión abierto X-TOLE mostraron una reducción de más del 90% en la frecuencia mensual media de crisis después de 30 meses.
2. Aproximadamente el 25% de los pacientes con azetukalner durante ≥2 años experimentaron ≥1 año de libertad de crisis.
3. Se informaron mejoras en la calidad de vida en adultos con FOS tratados con azetukalner.
4. Xenon está llevando a cabo tres ensayos de Fase 3 para azetukalner en FOS y en las crisis tonico-clónicas primarias generalizadas (PGTCS).
제논 제약 (Nasdaq:XENE)는 제15회 유럽 간질 학회에서 아제투칼너라는 새로운 Kv7 채널 개방제의 장기 데이터를 보여주는 세 개의 포스터를 발표했습니다. 주요 내용은 다음과 같습니다:
1. X-TOLE 오픈라벨 확장 연구에 참여한 환자들은 30개월 후 매달 발작 빈도가 90% 이상 감소했습니다.
2. 아제투칼너를 2년 이상 투여받은 환자의 약 25%가 1년 이상의 발작 자유를 경험했습니다.
3. 아제투칼너로 치료받은 FOS 성인 환자들에서 삶의 질이 개선되었다는 보고가 있었습니다.
4. 제논은 FOS와 원발성 전신 근간대성 발작(PGTCS) 치료를 위해 아제투칼너에 대한 세 가지 3상 시험을 진행하고 있습니다.
Xenon Pharmaceuticals (Nasdaq:XENE) a présenté trois affiches lors du 15e Congrès Européen sur l'Épilepsie, montrant des données à long terme sur azetukalner, un nouvel ouvreur de canal Kv7 pour le traitement des crises d'apparition focale (FOS). Les points clés incluent :
1. Les patients de l'étude d'extension ouverte X-TOLE ont montré une réduction de plus de 90 % de la fréquence mensuelle médiane des crises après 30 mois.
2. Environ 25 % des patients traités avec azetukalner pendant ≥2 ans ont connu ≥1 an de liberté de crise.
3. Des améliorations de la qualité de vie ont été rapportées chez des adultes atteints de FOS traités avec azetukalner.
4. Xenon mène trois essais de Phase 3 pour azetukalner dans les cas de FOS et de crises tonico-cloniques généralisées primaires (PGTCS).
Xenon Pharmaceuticals (Nasdaq:XENE) präsentierte drei Poster auf dem 15. Europäischen Epilepsie-Kongress, die Langzeitdaten zu azetukalner, einem neuen Kv7-Kanalöffner, zur Behandlung von fokalen Anfällen (FOS) zeigen. Die wichtigsten Punkte sind:
1. Patienten in der offenen X-TOLE-Erweiterungsstudie zeigten nach 30 Monaten eine Reduktion der medianen monatlichen Anfallshäufigkeit um mehr als 90 %.
2. Ungefähr 25 % der Patienten, die azetukalner seit ≥2 Jahren einnahmen, erlebten ≥1 Jahr Anfallfreiheit.
3. Verbesserungen der Lebensqualität wurden bei Erwachsenen mit FOS berichtet, die mit azetukalner behandelt wurden.
4. Xenon führt drei Phase-3-Studien zu azetukalner bei FOS und primären generalisierten tonisch-klonischen Anfällen (PGTCS) durch.
- Azetukalner showed >90% reduction in median monthly seizure frequency after 30 months in X-TOLE open-label extension study
- About 25% of patients on azetukalner for ≥2 years experienced ≥1 year of seizure freedom
- Quality of life improvements reported in adults with focal onset seizures treated with azetukalner
- Azetukalner is the most advanced, clinically validated potassium channel modulator in late-stage development for multiple indications
- None.
Insights
The long-term data presented for azetukalner in focal onset seizures is highly promising. Patients in the open-label extension study for up to 30 months showed a
The quality of life improvements reported are also significant. Epilepsy often has substantial impacts beyond seizures, including anxiety, depression and fatigue. Demonstrating improvements in patient-reported outcomes alongside seizure reduction strengthens azetukalner's clinical profile. However, it's important to note that open-label extension data can be subject to bias and these results should be confirmed in the ongoing Phase 3 trials.
Xenon's progress with azetukalner is encouraging for investors. As the most advanced Kv7 channel opener in late-stage development, it has potential in multiple indications including focal onset seizures, primary generalized tonic-clonic seizures and major depressive disorder. This broad potential market could translate to significant revenue if approved.
The company's ongoing Phase 3 program, with three clinical trials, demonstrates confidence in the drug's potential. However, investors should note that success in Phase 2b doesn't guarantee Phase 3 success. The epilepsy market is competitive, with established players and generic options. Xenon will need to demonstrate clear superiority or differentiation to gain market share. The company's focus on patient-reported outcomes and quality of life measures could be a key differentiator if reflected in Phase 3 results.
- 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
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 Seizures
Presenter: Jacqueline A. French, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
Session 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, Germany
Session Times: Daily from 1:30-3:00 pm CEST
Poster Tour: S2 Clinical Neurophysiology/Drug Therapy
Poster #P406: Non-seizure Symptoms, Mental Health Comorbidities, and Quality of Life in Patients Reporting Focal Onset Seizures
Presenter: 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 Program
Xenon’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 Statement
This 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 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
FAQ
What is the primary efficacy endpoint in Xenon's (XENE) Phase 3 X-TOLE trials for azetukalner?
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