Xenon Showcases Azetukalner Data at 15th European Epilepsy Congress

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• Three presentations highlight long-term data and improved quality of life outcomes. In adults with focal seizures

VANCOUVER, British Columbia and BOSTON, Sept. 9, 2024 (GLOBE NEWSWIRE) — XENON Pharmaceuticals, Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing and delivering life-changing therapies to patients in need, today announced three poster presentations at the 15th European Epilepsy Congress (EEC) in Rome, Italy. Azetocalner, a novel, potent Kv7 channel opener, is the most advanced, clinically proven 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).

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“We are excited about this opportunity to engage with leading epilepsy physicians at the EEC in Rome and share long-term azitocalner data from the ongoing X-TOLE open-label extension study. Azitocalner represents the only Kv7 potassium channel opener in clinical development supported by Phase 2b data as well as long-term efficacy and safety data in patients with epilepsy,” said Dr. Christopher Kenny, Chief Medical Officer at Xenon. “These data are particularly impressive given the severity of the baseline disease, with patients who exceeded 30 months in the open-label extension study demonstrating a greater than 90% reduction in mean monthly seizure frequency, while nearly one in four patients taking azitocalner for at least two years in OLE experienced a seizure-free period of one year or more.”

“We also present patient-reported survey data that demonstrate the significant burden of disease on people living with epilepsy, with reduced quality of life, increased seizure frequency and fatigue, as well as other comorbidities such as anxiety and depression, underscoring the need for new medications to help people living with epilepsy,” Dr. Kenny continued.

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Presentations at EEC:

Sticker #P282:
Azitocalner (XEN1101), a novel, potent Kv7 potassium channel opener: interim data from an ongoing, long-term, open-label, phase 2b study (X-TOLE) in adults with focal seizures
Presenter: Jacqueline A. French, NYU Grossman School of Medicine and NYU Langone Health, New York, NY
Session times: Daily from 1:30-3:00 PM CEST

Sticker #P281: Long-Term Improvements in Quality of Life on the Epilepsy Inventory-31 (QOLIE-31) in Adults with Focal Seizures Treated with Azitocalner (XEN1101) in an Ongoing Open-Ended Extension of the Phase 2b Study (X-TOLE)
Presenter: Christian Brandt, Bethel Epilepsy Center, Mara Hospital, University Epilepsy Hospital, Bielefeld, Germany
Session times: Daily from 1:30-3:00 PM CEST
Poster Tour: S2 Clinical Neurophysiology/Pharmacotherapeutics

Sticker #P406:
Non-seizure symptoms, mental health comorbidities, and quality of life in patients with focal seizures
Presenter: Cynthia Hardin, Xenon Pharmaceuticals
Session times: Daily from 1:30-3:00 PM CEST

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Posters will be available for viewing at the conference from Sunday, September 8 through Tuesday, September 10 at 4:00 p.m. CEST and will be added to Xenon site In line with the conference guidelines, Xenon is also hosting a scientific exhibition at site SE1, stand 346.

About Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals (Nasdaq: XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing and commercializing innovative therapies to improve the lives of people with neurological and psychiatric disorders. We are developing a new pipeline to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, our breakthrough Kv7 channel activator, represents the most advanced and clinically proven potassium channel modulator in late-stage clinical development for multiple indications. For more information, please visit www.xenon-pharma.com.

About the Azitocalner Phase III Epilepsy Treatment 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). The Phase 3 X-TOLE clinical trials are closely modeled after the Phase 2b X-TOLE clinical trial and are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the clinical efficacy, safety and tolerability of azitocalner 15 mg or 25 mg with food as add-on therapy in approximately 360 patients with FOS per study. The primary efficacy endpoint is the mean percentage change (MPC) in monthly seizure frequency from baseline to the double-blind period (DBP) for azitocalner compared to placebo. X-ACKT is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of 25 mg azitocalner with food as adjunctive therapy in approximately 160 patients with PGTCS. The primary efficacy endpoint is MPC in monthly PGTCS recurrence from baseline to DBP for azitocalner compared to placebo.

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Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical facts and include statements regarding the timing and results of potential clinical trials; the potential efficacy, safety profile, future development plans in current and anticipated indications; the addressable market, regulatory success and commercial potential of our product candidates and our partners; the effectiveness of our clinical trial designs; our ability to successfully develop and achieve milestones in our azitocalner and other pipeline and development programs; and our ability to successfully develop and obtain regulatory approval for azitocalner and other product candidates. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that could cause actual results, events or developments to differ materially 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 the safety and efficacy of any of our or our partners’ product candidates; promising results from preclinical development activities or early clinical trial results may not be replicated in subsequent clinical trials; our assumptions regarding our planned expenditures and the adequacy of our cash to fund operations may prove incorrect; our ongoing discovery and preclinical efforts may not yield additional product candidates; any of our or our partners’ product candidates, including Azetocalner, may fail to develop, may not receive required regulatory approvals, or may be delayed to the point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partner programs; regulatory authorities 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 expanding product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; In addition to other risks identified in our filings with the U.S. Securities and Exchange Commission and the securities commissions of British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we undertake 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 are the property of their respective owners.

Contacts:
For investors:
Chad run away
Vice President of Investor Relations
(857) 675-7275
investors@xenon-pharma.com

For media:
Colin’s reflection
Senior Vice President, Corporate Affairs
(617) 671-9238
Media@xenon-pharma.com

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