AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) said on Monday that it has completed dosing the final patient in its Phase 2b Elumina clinical trial evaluating investigational therapy VLS-01 for adults with treatment-resistant depression (TRD), with topline results expected in the fourth quarter of 2026.
The randomized, double-blind, placebo-controlled trial enrolled 156 patients across multiple centers. The study is designed to assess the efficacy, safety and tolerability of VLS-01, an oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT), compared with placebo.
The trial's primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 29. Secondary and exploratory endpoints include changes in MADRS scores at weeks six and 14, Columbia-Suicide Severity Rating Scale (C-SSRS) scores, and safety and tolerability assessments.
The announcement marks a clinical operations milestone rather than an efficacy update. The company said safety and efficacy data will be released with the anticipated topline readout later this year.
AtaiBeckley CEO Srinivas Rao said completing enrollment and dosing keeps the company on track for the expected data release and allows it to outline the planned development strategy for VLS-01.
“We intend to advance VLS-01 into major depressive disorder in Phase 3, subject to supportive Phase 2 results, where the same mechanistic rationale applies and where we can reach patients who fall outside the TRD definition but carry a similar burden of disease,” Rao said.
“We also see generalized anxiety disorder as a significant future opportunity for VLS-01, given the scale of unmet need, the mechanistic profile of the compound, and VLS’s design to fit within a two-hour treatment session - a meaningful advantage for a chronic indication where patients could require repeat visits over time.”
The Elumina study includes two placebo-controlled administrations of VLS-01 or placebo given two weeks apart, followed by a 12-week monitoring period. Participants are then re-randomized to receive one of two dose strengths of VLS-01 in a non-placebo-controlled treatment phase to further evaluate safety and efficacy.
AtaiBeckley said its development strategy positions VLS-01 alongside BPL-003, another investigational therapy currently in Phase 3 development for treatment-resistant depression that has received US Food and Drug Administration Breakthrough Therapy Designation.
The company said the two programs are intended to address different segments of mood and anxiety disorders if successfully developed and approved.
“Together, BPL-003 and VLS-01 position AtaiBeckley to serve patients across the spectrum of mood and anxiety disorders, from the most severe and refractory to those who have yet to see a meaningful advance in care,” Rao concluded.