Atai Life Sciences N.V. announced the completion of the Phase 1 study of VLS-01 in healthy participants. 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 first half of 2024.