atai Life Sciences Announces First Participant Dosed in Phase 1b Trial of VLS-01

NEW YORK and BERLIN, March 04, 2024 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that the first healthy participant has been dosed in the Phase 1b trial of VLS-01, an oral transmucosal film (OTF) formulation of N,N-dimethyltryptamine (DMT).

The Phase 1b study is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT.  This single center, open label study is anticipated to enroll a total of 16 healthy participants. Participants will initially receive a single dose of IV DMT followed by 3 different doses of VLS-01, with a 28-day washout window between administrations. Top-line results for the Phase 1b study are expected in the second half of this year.

“I am delighted with the swift progress our team has made to commence dosing in the Phase 1b trial,” said atai Co-founder and Chief Executive Officer, Florian Brand. “Our proprietary oral transmucosal formulation of DMT, VLS-01, is designed to induce a short psychedelic effect to allow for scalability and broad patient access. VLS-01 is expected to fit into an established interventional psychiatry treatment paradigm of 2 hours in the clinic and is anticipated to offer a more patient and physician-friendly experience compared to intravenous administration.”

Results from the previous Phase 1 single ascending dose trial were the basis for further formulation optimization, which included the incorporation of taste masking, the addition of a backing layer, and enhancements to further increase permeability. The optimized formulation currently being tested is designed to improve PK and the patient experience ahead of moving into an anticipated Phase 2 trial with VLS-01 in TRD.

About VLS-01
VLS-01 is a proprietary OTF formulation of DMT being developed for patients living with treatment-resistant depression. Pharmacologically, DMT is a partial agonist of the 5-HT 1A/2A/2C receptors, characterized by an intrinsically short duration of psychedelic effect. Clinical evidence suggests that a single administration of IV DMT results in rapid-acting and durable antidepressant effects in patients with major depressive disorder. The company’s proprietary OTF formulation is designed to eliminate the need for IV administration, provide improved PK compared to such route of administration, and maximize the therapeutic potential of a 2 hour in-clinic patient visit.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.

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