Atai Life Sciences announces first patint dosed in Phase 1b trial of VLS-01

atai Life Sciences announced that the first healthy participant has been dosed in the Phase 1b trial of VLS-01, an oral transmucosal film formulation of N,N-dimethyltryptamine. The Phase 1b study is designed to evaluate the relative safety, tolerability, pharmacokinetics and pharmacodynamics of an optimized OTF formulation of VLS-01, compared to intravenous 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. 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.