atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that the first patient has been dosed in its Phase 2 Elumina trial of VLS-01, the company’s oral transmucosal film formulation of DMT applied to the buccal surface, in participants with treatment-resistant depression.
Topline results are expected from the first treatment phase of the trial in the first quarter of 2026.
"Dosing the first patient in the Phase 2 Elumina trial of VLS-01 marks a significant milestone in our commitment to transforming the treatment landscape for mental health disorders," atai’s chief medical officer Dr Kevin Craig said in a statement.
Dr Craig noted that millions of people globally struggle with treatment-resistant depression, often with few or no viable treatment options.
"With VLS-01, we see the potential to offer rapid, robust, and durable antidepressant effects that could provide meaningful relief where existing treatments fall short,” Dr Craig said. “This trial brings us one step closer to delivering a new and innovative solution to those people who need it most."
The Elumina trial is a multi-center, double-blind, randomized, placebo-controlled study evaluating the efficacy, safety, and tolerability of repeated VLS-01 doses.
Trial design
VLS-01 is designed to align with the established two-hour interventional psychiatry treatment framework, enabling integration into current care models.
The trial has two treatment periods. In the first period, about 142 patients will be randomized 1:1 to receive either a 120mg dose of VLS-01 or a placebo on Day 1, followed by a second dose at Week 2.
The primary outcome measure is the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4.
The final double-blind assessment visit is scheduled for Week 14, providing 12 weeks of blinded durability data after two doses.
The second treatment period begins at Week 14, where patients will be randomized 1:1 to receive a third dose of either 60mg or 120mg of VLS-01.
Final safety and efficacy assessments will occur two weeks after this third dose.