Announcement • Jul 06
Ataibeckley Doses Last Patient in Elumina Phase 2B Clinical Trial for Vls-01 and Plans Phase 3 in Major Depressive Disorder
AtaiBeckley Inc. announced that the last patient has been dosed in Elumina, its Phase 2b clinical trial evaluating VLS-01 in adults living with treatment-resistant depression. The study randomized 156 patients, with topline data expected in the Fourth Quarter 2026. Investigational product: VLS-01. Formulation: Proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT). Mechanism of action: Serotonin agonist at 5HT1/2/6/7 receptors. Indication: Treatment-resistant depression. Study name: Elumina. Design: Multi-center, double-blind, randomized, placebo-controlled Phase 2b. 156 patients randomized 1:1. ClinicalTrials.gov identifier NCT06524830. Primary outcome: VLS-01 versus placebo mean change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 29. Secondary and exploratory outcomes: Placebo-adjusted mean change from Baseline in MADRS total score at weeks 6 and 14, Columbia-Suicide Severity Rating Scale (C-SSRS) scores, safety and tolerability. Upcoming milestones: Topline data readout anticipated Fourth Quarter 2026. Elumina is an international Phase 2b, multi-center, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy, safety, and tolerability of repeated dosing of VLS-01 in adults living with treatment-resistant depression. Participants are randomized 1:1 to receive VLS-01-BU (a buccal oral transmucosal film formulation of VLS-01) or placebo during the placebo-controlled treatment period. Participants receive a total of two double-blind administrations, delivered via the buccal transmucosal route, with a two-week interval between each administration. Following the second dose, all participants enter a 12-week placebo-controlled follow-up period, during which depressive symptoms, safety, and tolerability are systematically monitored. After completion of the placebo-controlled treatment and observation period, all participants are re-randomized 1:1 to receive a single additional double-blind administration of VLS-01-BU during a non-placebo-controlled treatment period. In this phase, participants receive either dose strength 1 or dose strength 2 of VLS-01-BU, enabling further characterization of safety and efficacy across dose levels. Final safety and efficacy assessments are conducted two weeks following administration of the third dose. Subject to a supportive Phase 2 readout and regulatory alignment, AtaiBeckley intends to advance VLS-01 into major depressive disorder in a Phase 3 program. TRD and MDD share substantial clinical and mechanistic overlap, and a positive result in the TRD population would provide a strong scientific basis for the MDD program. The Company also sees generalized anxiety disorder as a potential fast follower indication for VLS-01, given the serotonergic mechanism and the scale of unmet need in that space. The Elumina trial is focused on treatment-resistant depression. Subject to a supportive Phase 2 readout, AtaiBeckley intends to advance VLS-01 into major depressive disorder in Phase 3. TRD and MDD share significant mechanistic and clinical overlap, and a positive result in TRD would provide a strong scientific basis for an MDD program. The Company also sees generalized anxiety disorder as a potential fast follower. BPL-003, AtaiBeckley's other late-stage asset, is concurrently advancing through Phase 3 in TRD, giving the Company the potential for differentiated coverage across the spectrum of depressive illness. BPL-003 and VLS-01 are distinct investigational compounds being developed as complementary assets. BPL-003 has received FDA Breakthrough Therapy Designation for TRD and is advancing through Phase 3 in that indication. VLS-01, as a differentiated compound currently in Phase 2b in TRD, offers a separate development pathway into the broader MDD population subject to supportive results. AtaiBeckley anticipates reporting topline Phase 2 data from Elumina in the Fourth Quarter 2026. VLS-01 is a proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) being developed by AtaiBeckley as a potential treatment for depression. Initial, Phase 2 clinical development is focused on treatment-resistant depression, with Phase 3 development in major depressive disorder planned subject to Phase 2 results. Pharmacologically, VLS-01 is a partial to full agonist of the 5-HT1/2/6/7 sub-receptors and is being developed to potentially offer rapid, robust, and durable efficacy with a favorable safety profile. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, positioning it for integration into existing care models. VLS-01 is an investigational product and has not been approved by the FDA or any other regulatory body.
