AtaiBeckley Completes Patient Dosing in Phase 2b Trial of VLS-01 for Treatment-Resistant Depression

AtaiBeckley Reaches Key Clinical Milestone

AtaiBeckley Inc., a clinical-stage biotechnology company developing next-generation mental health treatments, has announced that the last patient has been dosed in its Phase 2b Elumina clinical trial evaluating VLS-01 for adults living with treatment-resistant depression (TRD).

The study enrolled and randomized 156 patients, marking an important milestone in the clinical development of the investigational therapy. The company expects to report topline results from the trial in the fourth quarter of 2026.

Trial Moves One Step Closer to Results

The completion of patient dosing means all participants have now received their assigned treatment, allowing researchers to complete follow-up assessments before analyzing the data.

According to AtaiBeckley, the upcoming results will help determine the next stage of development for VLS-01 and guide future regulatory discussions.

Company Plans to Expand Beyond Treatment-Resistant Depression

AtaiBeckley says VLS-01 may eventually be developed for a broader group of patients with depression.

Srinivas Rao, Co-founder and Chief Executive Officer of AtaiBeckley, said the company intends to move VLS-01 into a Phase 3 program for major depressive disorder (MDD), provided the Phase 2 study produces positive results.

He explained that treatment-resistant depression and major depressive disorder share many biological and clinical characteristics, making VLS-01 a potential option for patients who do not meet the strict definition of treatment-resistant depression but still experience significant symptoms.

The company also sees generalized anxiety disorder (GAD) as another possible future indication because of the drug's mechanism of action and its treatment format, which is designed to fit into a two-hour clinical session.

How the Elumina Study Was Designed

Elumina is an international, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial.

Participants were randomly assigned to receive either VLS-01 or placebo during the initial treatment period.

VLS-01 is administered as a buccal oral transmucosal film, allowing the medicine to be absorbed through the inside of the cheek.

Patients received two treatment sessions spaced two weeks apart. After the second dose, participants entered a 12-week follow-up period where researchers monitored changes in depressive symptoms along with the treatment's safety and tolerability.

Following the placebo-controlled portion of the study, participants entered another treatment period where they received an additional dose of VLS-01 at one of two dose levels. This phase is designed to collect more information about the therapy's safety and effectiveness.

What Is VLS-01?

VLS-01 is an investigational oral transmucosal film formulation containing N,N-Dimethyltryptamine (DMT).

The therapy is being developed as a rapid-acting treatment for depression and works by targeting several serotonin receptors involved in mood regulation.

According to AtaiBeckley, VLS-01 is designed to provide fast, durable symptom relief while fitting into an existing two-hour interventional psychiatry treatment model, making it easier to integrate into current clinical practice.

The therapy remains investigational and has not been approved by the US Food and Drug Administration (FDA) or any other regulatory authority.

Major Depressive Disorder and Anxiety Become Future Focus Areas

Subject to positive Phase 2 results and regulatory discussions, AtaiBeckley plans to begin Phase 3 development of VLS-01 in patients with major depressive disorder.

The company also believes generalized anxiety disorder could become another important development opportunity because many patients continue to have limited treatment options despite currently available therapies.

Expanding a Mental Health Treatment Pipeline

VLS-01 is one of several mental health therapies currently being developed by AtaiBeckley.

The company's pipeline also includes BPL-003, a mebufotenin benzoate nasal spray that is already in Phase 3 development for treatment-resistant depression after receiving Breakthrough Therapy Designation from the FDA.

Another investigational program, EMP-01, is being studied as a potential treatment for social anxiety disorder.

Alongside these clinical programs, AtaiBeckley is also developing non-hallucinogenic serotonin receptor agonists for conditions including opioid use disorder and treatment-resistant depression, as part of its broader effort to expand treatment options for people living with mood and anxiety disorders.

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