PRISM Psychedelics Index: atai Life Sciences Doses First Patient in Psychedelic Treatment Trial

Biopharmaceutical company, atai Life Sciences (Nasdaq: ATAI) joined the PRISM MarketView Emerging Psychedelics Index this week. The company was founded in response to the significant unmet need and lack of innovation in the mental health treatment landscape, and aims to transform the treatment of mental health disorders.

On Monday, atai announced it had dosed the first healthy participant in a Phase 1b trial of VLS-01, an oral transmucosal film (OTF) formulation of N,N-dimethyltryptamine (DMT). Top-line results for the study are expected in the second half of this year.

atai Co-founder and Chief Executive Officer, Florian Brand, said, “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.”

Highlights

atai’s study is designed to evaluate the relative safety, tolerability, pharmacokinetics and pharmacodynamics of an optimized OTF formulation of VLS-01, compared to intravenous DMT.

The single center, open label study expects to enroll 16 healthy participants who 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.

VLS-01 is a proprietary OTF formulation of DMT being developed for patients living with treatment-resistant depression. DMT offers a short-duration psychedelic effect and 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 OTF formulation is designed to eliminate the need for IV administration, and maximize the therapeutic potential of a 2 hour in-clinic patient visit.

The PRISM Psychedelics Index tracks small and micro-cap stocks that are developing or marketing legal psychedelic-derived products.

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.