AtaiBeckley, a clinical-stage biotechnology company focused on developing rapid-acting and durable treatments for mental health disorders, has completed dosing the final patient in its Phase 2b Elumina clinical trial evaluating VLS-01 in adults with Treatment-Resistant Depression (TRD). The international study enrolled and randomised 156 patients, with topline results expected in the fourth quarter of 2026.

The milestone marks a significant step in the clinical development of VLS-01, an investigational oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT), as the company seeks to expand its pipeline of novel therapies for mood and anxiety disorders.

Commenting on the development, Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley, said completing enrollment and dosing in the Elumina trial keeps the company on track for its anticipated Q4 2026 topline data readout. He added that, alongside the ongoing Phase 3 development of BPL-003 for treatment-resistant depression, the company intends to position VLS-01 for broader use in patients with Major Depressive Disorder (MDD), subject to positive Phase 2 results.

According to Rao, AtaiBeckley also sees Generalized Anxiety Disorder (GAD) as a promising future indication for VLS-01 due to its mechanism of action and its design for administration within a two-hour treatment session, which could offer practical advantages for patients requiring repeated treatment. He noted that the combined development of BPL-003 and VLS-01 is intended to address a wide spectrum of mood and anxiety disorders, ranging from severe treatment-resistant conditions to broader patient populations with unmet therapeutic needs.

The Elumina study is a multinational, multi-centre, double-blind, randomized, placebo-controlled Phase 2b trial designed to evaluate the efficacy, safety and tolerability of repeated doses of VLS-01 in adults with treatment-resistant depression. Participants were randomized in a 1:1 ratio to receive either VLS-01 buccal oral transmucosal film or placebo during the placebo-controlled phase. The treatment consisted of two double-blind administrations delivered two weeks apart, followed by a 12-week monitoring period to assess depressive symptoms, safety and tolerability.

Following the placebo-controlled phase, participants are re-randomized to receive a third dose of VLS-01 at one of two dose strengths, allowing researchers to further evaluate the therapy's safety and efficacy across different dose levels. Final clinical assessments will be completed two weeks after the third administration.

Subject to supportive Phase 2 results and regulatory discussions, AtaiBeckley plans to initiate a Phase 3 programme evaluating VLS-01 in major depressive disorder. The company believes the scientific and clinical overlap between treatment-resistant depression and major depressive disorder provides a strong rationale for expanding the programme. Generalized anxiety disorder is also being considered as a potential future indication.

VLS-01 is designed to deliver DMT through a buccal oral film, targeting rapid, robust and durable antidepressant effects while fitting within the established two-hour interventional psychiatry treatment model. The therapy remains investigational and has not yet received approval from the US Food and Drug Administration (FDA) or any other regulatory authority.

AtaiBeckley's broader pipeline includes BPL-003, a mebufotenin benzoate nasal spray currently in Phase 3 development for treatment-resistant depression after receiving Breakthrough Therapy Designation from the FDA, and EMP-01, an (R)-MDMA hydrochloride therapy in Phase 2 development for social anxiety disorder. The company is also advancing drug discovery efforts aimed at developing non-hallucinogenic 5-HT2A receptor agonists for opioid use disorder and treatment-resistant depression.