– The Elumina trial is a Phase 2 study across multiple locations, using a double-blind, randomized, and placebo-controlled design. It aims to evaluate how well VLS-01 (buccal film DMT) works, how safe it is, and how well patients tolerate it when used to treat treatment-resistant depression.
– VLS-01 is under development as a fast-acting, strong, and long-lasting antidepressant for individuals with treatment-resistant depression, a condition affecting roughly 100 million people worldwide.
– VLS-01 is formulated to align with the standard two-hour treatment model used in interventional psychiatry.
– The primary findings from the Phase 2 Elumina trial are expected to be released in the first quarter of 2026.
NEW YORK and BERLIN, March 11, 2025 — (NASDAQ: ATAI) – Atai Life Sciences (“atai” or the “Company”), a biopharmaceutical company in the clinical stage focused on changing mental health disorder treatments, has announced the first patient has received a dose in the Phase 2 Elumina trial. This trial is testing VLS-01, atai’s unique formulation of N,N-Dimethyltryptamine (DMT) as an oral film applied to the inner cheek, for individuals with treatment-resistant depression (TRD).
“The first patient being dosed in the Phase 2 Elumina trial for VLS-01 is a key step in our dedication to transforming how mental health disorders are treated,” said Dr. Kevin Craig, Chief Medical Officer at atai. “Millions globally are affected by treatment-resistant depression, often with limited treatment options. VLS-01 has the potential to provide fast, strong, and lasting antidepressant effects, offering significant relief where current treatments are inadequate. This trial moves us closer to providing a new, innovative solution for those who need it most.”
Elumina is a Phase 2 clinical trial conducted at multiple centers, employing a double-blind, randomized, placebo-controlled design to assess the effectiveness, safety, and tolerability of repeated doses of VLS-01. The trial includes two treatment phases. In the first phase, about 142 patients will be randomly assigned in a 1:1 ratio to receive either a 120mg dose of VLS-01 or a placebo on Day 1, followed by a second dose of the same treatment at Week 2. The main goal is to measure the change from the start of the trial in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4. The final double-blind assessment will occur at Week 14. This initial phase will provide 12 weeks of data on how long the effects last after two doses of VLS-01, compared to a placebo. The primary results from this phase are expected in the first quarter of 2026.
The second treatment phase begins at Week 14 and will explore the effects of two different dosages of VLS-01. Patients will be randomly assigned in a 1:1 ratio to receive a third dose of either 60mg or 120mg of VLS-01. The final assessment of safety and effectiveness will be performed two weeks after the third dose is given.
About VLS-01 (buccal film DMT)
VLS-01 is a uniquely formulated oral film containing N,N-Dimethyltryptamine (DMT) that is applied to the inner cheek, designed for treating individuals with treatment-resistant depression (TRD). VLS-01 acts on the 5-HT1/2/6/7 receptors and is being developed to potentially deliver rapid, strong, and lasting results with a good safety profile. VLS-01 is designed to fit within the current two-hour interventional psychiatry treatment framework, making it suitable for integration into existing treatment approaches. Atai is currently enrolling participants in Elumina, the Phase 2 trial involving multiple centers, using a double-blind, randomized, placebo-controlled design to determine the efficacy, safety, and tolerability of VLS-01 in people with TRD. Topline results from the first treatment period of the Phase 2 Elumina trial are anticipated in the first quarter of 2026.
About atai Life Sciences
atai Life Sciences is a biopharmaceutical company in the clinical stage focused on changing the treatment of mental health disorders. It was established to address the significant unmet needs and lack of progress in mental health treatment. atai is committed to creating new, evidence-based treatments for depression, anxiety, and other mental health disorders. atai aims to improve mental health care, enabling individuals worldwide to live more fulfilling lives. For more information, please visit .
Forward-looking Statements
This press release includes forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. These statements are intended to be covered by the safe harbor provisions for forward-looking statements in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are used to identify forward-looking statements, although not all forward-looking statements include these terms. All statements in this release that are not historical facts should be considered forward-looking statements. These include, but are not limited to, statements about our business strategy and plans, and the potential, success, cost, and timing of VLS-01 development and related trials and studies.
Forward-looking statements are not guarantees, but involve known and unknown risks and uncertainties that may cause actual results to differ significantly from those projected. These risks include, but are not limited to, the factors described in the “Risk Factors” section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 28, 2024, and as updated in atai’s other filings with the SEC. atai does not commit to updating or revising any forward-looking statements in this press release, except as required by law.
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