atai Life Sciences Announces First Patient Dosed in Elumina, the Phase 2 Clinical Trial of VLS-01 for Treatment-Resistant Depression

Core Insights - atai Life Sciences has initiated the Phase 2 Elumina trial for VLS-01, a novel treatment for treatment-resistant depression (TRD) [1][2] - The trial aims to evaluate the efficacy, safety, and tolerability of VLS-01, with topline results expected in Q1 2026 [2][5] Company Overview - atai Life Sciences is a clinical-stage biopharmaceutical company focused on innovating treatments for mental health disorders, particularly depression and anxiety [4] - The company was founded to address the significant unmet needs in mental health treatment and aims to develop evidence-based therapeutics [4] Product Details - VLS-01 is an oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) designed for rapid and durable antidepressant effects [3][5] - The product acts as a partial to full agonist of the 5-HT1/2/6/7 receptors, fitting within a two-hour interventional psychiatry treatment paradigm [3][5] Trial Design - The Elumina trial is a multi-center, double-blind, randomized, placebo-controlled study involving approximately 142 patients [2][5] - The first treatment period includes two doses of VLS-01 (120mg) or placebo, with the primary endpoint being the change in MADRS total score at Week 4 [2][5]