Xenon Pharmaceuticals (NasdaqGM:XENE) 2025 Conference Transcript

Summary of Xenon Pharmaceuticals Conference Call Company Overview - Company: Xenon Pharmaceuticals (NasdaqGM:XENE) - Focus: Neurology, specializing in drug and ion channels in the central nervous system (CNS) [4][47] Key Programs and Milestones Lead Molecule: Azetukalner - Indications: Epilepsy and neuropsychiatry - Mechanism: Potassium channel modulator - Phase III Trials: - XTOL II for focal onset seizures, fully enrolled with 380 subjects [11][54] - Expected data readout in early 2026 [5][12] - Phase IIb Data: Showed best efficacy ever seen in a clinical trial for focal onset seizures with a 35% placebo-adjusted efficacy [5][48] - Neuropsychiatry Expansion: - Three ongoing Phase III trials for major depressive disorder (MDD) and bipolar depression [6][49] - XNOVA II and XNOVA III for MDD, and XCEED for bipolar depression [6][49] Pain Portfolio - New Targets: - Nav1.7 (XEN-1701) and Kv7, both in Phase I trials [6][50] - Nav1.7 has a strong genetic basis for pain signaling [38][39] - Future Plans: Aim to start Phase II proof of concept studies in 2027 [42][43] Market Opportunity - Epilepsy Market: - 3 million Americans have epilepsy; 60% have focal onset seizures [25][69] - Approximately 1 million patients could benefit from a new treatment [25][69] - Depression Market: - Focus on rapid onset and impact on anhedonia, differentiating from traditional SSRIs and SNRIs [31][76] Clinical Trial Design and Expectations - Phase III Design: - XTOL II and XTOL III are identical studies with the same inclusion-exclusion criteria [21][64] - High power assumptions: >99% at high dose and >90% at 15 mg dose [14][57] - Efficacy Expectations: - Confidence in reproducibility from Phase II to Phase III based on historical data [15][58] Regulatory and Commercialization Plans - NDA Submission: Expected in 2026, approximately six months after XTOL II data readout [21][64] - EMA Requirements: Likely need both XTOL II and XTOL III for submission [21][65] - DEA Scheduling: All anti-seizure medications are typically scheduled; specifics will depend on final data [66][67] Additional Insights - Adverse Event Profile: Azetukalner is expected to have a favorable profile compared to existing treatments, with no significant weight gain or sexual dysfunction [33][77] - Market Research: Positive feedback from psychiatrists regarding the novel mechanism and rapidity of onset [31][75] This summary encapsulates the key points discussed during the conference call, highlighting Xenon Pharmaceuticals' strategic focus, clinical developments, market opportunities, and regulatory plans.