• VLS-01, a proprietary oral transmucosal film (OTF) formulation of DMT, was well-tolerated with a favorable safety profile
  • Pharmacokinetic and pharmacodynamic data confirmed systemic delivery of DMT via the oral, transmucosal route at levels comparable to those achieved with IV administration
  • Company plans to further optimize VLS-01 in preparation for a Phase 2 study in treatment-resistant depression (TRD)

Atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the completion of the Phase 1 study of VLS-01 in healthy participants.

“We are pleased to report the completion of the Phase 1 study of VLS-01, in which we demonstrated a supportive PK/PD profile of our proprietary OTF formulation of DMT. We plan to test a further optimized version of our OTF formulation in a forthcoming Phase 1b prior to initiating a Phase 2 study in TRD.”

-Florian Brand, CEO and Co-Founder of atai

The Phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VLS-01 applied to the sublingual and buccal surfaces compared to intravenous (IV) DMT. The study enrolled a total of 74 healthy participants across three parts. The third part of the study evaluated VLS-01 administered and dosed as follows: sublingual 80mg (n=8), buccal 80mg with backing layer (n=10), and buccal 160mg with backing layer (n=8).

VLS-01 was well-tolerated with a favorable safety profile, and dose-dependent increases in exposure were observed. VLS-01 administration also resulted in subjective effects in most participants across doses. The company observed that participants that received 160mg of VLS-01 with a backing layer via buccal administration experienced the most robust and consistent increases in exposure and subjective effects compared to the other OTF cohorts, with results comparable to those seen in the IV cohort of DMT.

The company now plans to progress VLS-01 into a Phase 1b study in healthy participants. The study is expected to explore doses up to 160 mg with an optimized OTF formulation that incorporates taste masking, an intrinsic backing layer, and enhancements designed to increase permeability, with goals of further improving the participant experience and pharmacokinetics. The company has submitted a protocol to regulatory authorities and expects to enroll the first participant in a Phase 1b study in 1H 2024.

About VLS-01

VLS-01 is a proprietary OTF formulation of N,N-dimethyltryptamine (DMT). Pharmacologically, DMT is a partial agonist of the 5-HT 1A/2A/2C receptors, characterized by an intrinsically short duration of psychedelic effect, with a serum half-life estimated at less than 10 minutes. Clinical evidence suggests IV DMT administration results in rapid-acting antidepressant effects in patients with major depressive disorder (MDD). The company’s proprietary OTF formulation is designed to eliminate the need for parenteral administration, provide improved PK compared to such routes of administration, and result in a psychedelic effect that resolves by approximately 45 minutes post dosing, thus allowing for—and maximizing 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.