Xenon to Showcase Long-Term 36-Month Azetukalner Data at AAN 2025
Xenon Pharmaceuticals (XENE) has announced multiple presentations at the upcoming American Academy of Neurology Annual Meeting (AAN 2025) in San Diego. The company will showcase three key posters, highlighting significant progress in their epilepsy treatment research.
The main focus is on azetukalner, their novel Kv7 potassium channel opener, featuring 36-month long-term data from the ongoing X-TOLE open-label extension study in patients with focal onset seizures (FOS). The data demonstrates sustained monthly reduction in seizure frequency, impressive seizure freedom rates, and a consistent safety profile.
Additional presentations include an exploratory analysis showing reduced seizure frequency across four focal seizure subtypes, and patient survey findings regarding mental health and comorbidity burdens of FOS. The presentations will take place between April 5-9, 2025, with Xenon also hosting booth #1110 in the Exhibit Hall.
Xenon Pharmaceuticals (XENE) ha annunciato diverse presentazioni al prossimo Congresso Annuale dell'Accademia Americana di Neurologia (AAN 2025) a San Diego. L'azienda presenterà tre poster chiave, evidenziando i progressi significativi nella ricerca sul trattamento dell'epilessia.
Il focus principale è su azetukalner, il loro nuovo apritore del canale del potassio Kv7, con dati a lungo termine di 36 mesi dallo studio in aperto X-TOLE in corso su pazienti con crisi focali (FOS). I dati dimostrano una riduzione sostenuta della frequenza delle crisi mensili, tassi impressionanti di libertà dalle crisi e un profilo di sicurezza coerente.
Le presentazioni aggiuntive includono un'analisi esplorativa che mostra una riduzione della frequenza delle crisi attraverso quattro sottotipi di crisi focali, e i risultati di un sondaggio sui pazienti riguardanti la salute mentale e i carichi di comorbidità delle FOS. Le presentazioni si svolgeranno tra il 5 e il 9 aprile 2025, con Xenon che ospiterà anche lo stand #1110 nella Hall Espositiva.
Xenon Pharmaceuticals (XENE) ha anunciado múltiples presentaciones en la próxima Reunión Anual de la Academia Americana de Neurología (AAN 2025) en San Diego. La compañía mostrará tres carteles clave, destacando avances significativos en su investigación sobre el tratamiento de la epilepsia.
El enfoque principal está en azetukalner, su nuevo abridor del canal de potasio Kv7, que presenta datos a largo plazo de 36 meses del estudio de extensión en abierto X-TOLE en pacientes con crisis de inicio focal (FOS). Los datos demuestran una reducción mensual sostenida en la frecuencia de las crisis, tasas impresionantes de libertad de crisis y un perfil de seguridad consistente.
Las presentaciones adicionales incluyen un análisis exploratorio que muestra la reducción de la frecuencia de crisis en cuatro subtipos de crisis focales, y los hallazgos de una encuesta a pacientes sobre la salud mental y las cargas de comorbilidad de las FOS. Las presentaciones tendrán lugar entre el 5 y el 9 de abril de 2025, y Xenon también tendrá el stand #1110 en el Salón de Exposiciones.
제논 제약 (XENE)이 샌디에고에서 열리는 미국 신경학회 연례 회의 (AAN 2025)에서 여러 발표를 발표했습니다. 이 회사는 간질 치료 연구에서의 중요한 진행 상황을 강조하는 세 가지 주요 포스터를 선보일 예정입니다.
주요 초점은 아제투칼너 (azetukalner), 새로운 Kv7 칼륨 채널 개방제로, 초점 발작 (FOS) 환자에 대한 진행 중인 X-TOLE 오픈 라벨 확장 연구의 36개월 장기 데이터를 특징으로 합니다. 데이터는 발작 빈도의 지속적인 월간 감소, 인상적인 발작 자유율 및 일관된 안전성 프로필을 보여줍니다.
추가 발표에는 네 가지 초점 발작 하위 유형에서 발작 빈도의 감소를 보여주는 탐색적 분석과 FOS의 정신 건강 및 동반 질병 부담에 대한 환자 설문 조사 결과가 포함됩니다. 발표는 2025년 4월 5일부터 9일 사이에 진행되며, 제논은 전시홀에서 부스 #1110도 운영할 예정입니다.
Xenon Pharmaceuticals (XENE) a annoncé plusieurs présentations lors de la prochaine Réunion Annuelle de l'Académie Américaine de Neurologie (AAN 2025) à San Diego. L'entreprise présentera trois affiches clés, mettant en avant des progrès significatifs dans sa recherche sur le traitement de l'épilepsie.
Le principal axe est azetukalner, leur nouvel ouvreur de canal potassique Kv7, présentant des données à long terme de 36 mois provenant de l'étude d'extension ouverte X-TOLE en cours chez des patients souffrant de crises d'apparition focale (FOS). Les données montrent une réduction mensuelle soutenue de la fréquence des crises, des taux impressionnants de liberté vis-à-vis des crises et un profil de sécurité cohérent.
Les présentations supplémentaires incluent une analyse exploratoire montrant une réduction de la fréquence des crises à travers quatre sous-types de crises focales, ainsi que des résultats d'enquête auprès des patients concernant la santé mentale et les charges de comorbidité des FOS. Les présentations auront lieu entre le 5 et le 9 avril 2025, avec Xenon également présent au stand #1110 dans le hall d'exposition.
Xenon Pharmaceuticals (XENE) hat mehrere Präsentationen auf dem bevorstehenden Jahrestreffen der American Academy of Neurology (AAN 2025) in San Diego angekündigt. Das Unternehmen wird drei wichtige Poster präsentieren, die bedeutende Fortschritte in der Forschung zu Epilepsiebehandlungen hervorheben.
Der Hauptfokus liegt auf azetukalner, ihrem neuartigen Kv7-Kaliumkanalöffner, der 36-monatige Langzeitdaten aus der laufenden X-TOLE-Studie mit offener Etikette bei Patienten mit fokalen Anfällen (FOS) enthält. Die Daten zeigen eine anhaltende monatliche Reduktion der Anfallshäufigkeit, beeindruckende Raten an Anfallfreiheit und ein konsistentes Sicherheitsprofil.
Zusätzliche Präsentationen umfassen eine explorative Analyse, die eine reduzierte Anfallshäufigkeit über vier Subtypen fokaler Anfälle zeigt, sowie Ergebnisse einer Patientenbefragung zu psychischer Gesundheit und Komorbiditätsbelastungen bei FOS. Die Präsentationen finden zwischen dem 5. und 9. April 2025 statt, wobei Xenon auch Stand #1110 in der Ausstellungshalle haben wird.
- Long-term data shows sustained seizure frequency reduction and impressive seizure freedom rates
- Consistent safety profile demonstrated over 36 months
- Efficacy shown across multiple focal seizure subtypes
- Substantial clinical data with over 700+ patient-years
- None.
Insights
Xenon's announcement of 36-month data for azetukalner represents meaningful clinical progress for their lead asset in epilepsy. Long-term extension studies are critical for anti-seizure medications, as they address the chronic nature of epilepsy treatment and regulatory requirements for safety databases.
The sustained seizure reduction and maintained seizure freedom rates over 3 years provide compelling evidence of durable efficacy, addressing a significant concern with many anti-seizure medications where efficacy can wane over time due to tolerance. The consistent safety profile through 700+ patient-years of exposure significantly derisks the regulatory pathway, as safety concerns typically emerge with expanded patient exposure.
The mechanistic differentiation as a Kv7 potassium channel opener represents a novel approach in the treatment-resistant epilepsy space. The expanded subtype analysis showing efficacy across four focal seizure subtypes suggests potential versatility in clinical application and could support broader labeling.
For a specialty neurological condition like focal onset seizures, demonstration of long-term efficacy is particularly valuable, as patients typically require lifelong therapy. The additional patient survey findings on mental health burden likely support the company's understanding of patient needs and potential quality-of-life improvements with seizure control.
This clinical update provides meaningful derisking for Xenon's lead asset azetukalner. The 36-month data from X-TOLE's open-label extension solidifies the drug's long-term efficacy and safety profile with 700+ patient-years of accumulated data - an impressive milestone for a novel seizure mechanism.
The additional exploratory analysis showing efficacy across focal seizure subtypes expands azetukalner's potential market opportunity. This positive clinical progression strengthens Xenon's position as they advance what appears to be the most clinically validated potassium channel modulator in late-stage development.
For a non-commercial biotech company like Xenon (market cap ~$2.3B), lead asset derisking is particularly significant. Focal onset seizures represent a substantial market opportunity with persistent unmet needs despite available treatments. While not explicitly mentioned, the consistent safety profile is particularly important for chronic epilepsy therapies where tolerability directly impacts adherence and quality of life.
The findings being presented at a major neurology conference (AAN) provides scientific visibility that could impact key opinion leader perception. While this update doesn't change Xenon's immediate financial position, it incrementally enhances the long-term value proposition by further validating their scientific approach and development execution in a challenging neurological indication.
- Three epilepsy posters to be presented in scientific sessions at the American Academy of Neurology meeting
- Long-term 36-month data from the ongoing X-TOLE OLE study of azetukalner in focal onset seizures (FOS)
- Exploratory analysis of efficacy of azetukalner in FOS seizure sub-types
- Patient survey findings on mental health and comorbidity burdens of FOS
VANCOUVER, British Columbia and BOSTON, April 04, 2025 (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 multiple presentations at the upcoming American Academy of Neurology Annual Meeting (AAN 2025), taking place April 5-9, 2025 in San Diego, CA. Three posters will be presented, including long-term data from the ongoing X-TOLE open-label extension (OLE) study of azetukalner in patients with focal onset seizures (FOS). The Company will also present an exploratory efficacy analysis of FOS seizure subtypes from the X-TOLE study, as well as patient survey findings about the mental health and comorbidity burdens of FOS.
“Building upon more than 700+ patient-years of data to date, we are excited to share our 36-month azetukalner data from our ongoing X-TOLE open-label extension study in FOS showing sustained monthly reduction in seizure frequency, impressive seizure freedom rates, and a consistent AE safety profile suggesting long-term efficacy and tolerability of azetukalner,” stated Dr. Christopher Kenney, Chief Medical Officer of Xenon. “We are also presenting an exploratory analysis from our X‑TOLE study showing reduced seizure frequency rate across four focal seizure subtypes. These promising data sets support our conviction that azetukalner may offer hope for people who continue to seek new efficacious and well-tolerated therapies to address the debilitating impacts of uncontrolled seizures.”
- Poster 9‑001: Long-term Safety and Efficacy of Azetukalner, a Novel, Potent Kv7 Potassium Channel Opener in Adults With Focal Epilepsy: Update From the Ongoing 7-year Open-Label Extension of X-TOLE
Presenter: Jacqueline A. French, MD, New York University Grossman School of Medicine and NYU Langone Health
Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials
Date/Time: April 8 from 8:00 am – 9:00 am PT
- Poster 9-012: Efficacy of Azetukalner in Focal Onset Seizure (FOS) Subtypes: Results From the Double‑Blind, Placebo‑Controlled X‑TOLE Study
Presenter: Constanza Luzon Rosenblut, MD, Xenon Pharmaceuticals
Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials
Date/Time: April 8 from 8:00 am – 9:00 am PT
- Poster 9‑001: Is the Mental Health Burden of Epilepsy Under-Recognized in Patients Reporting Focal Onset Seizures? A Patient-Reported Outcomes Study
Presenter: Joanne M. Wagner, PhD, Xenon Pharmaceuticals
Session: P6: Epilepsy/Clinical Neurophysiology (EEG): Health Care Utilization and Disparities in Epilepsy
Date/Time: April 7 from 11:45 am – 12:45 pm PT
Exhibit Hall
Xenon is hosting booth #1110 in the Exhibit Hall, which is scheduled to open at 11:30 am PT on Saturday, April 6 and close on Wednesday, April 9 at 4:00 pm PT.
About Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals (Nasdaq: XENE) is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics. We are advancing an ion channel product portfolio to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, a novel, highly potent, selective Kv7 potassium 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.
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
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