Business
atai Life Sciences Announces Positive Preliminary Results from Phase 1b Trial of VLS-01 (Buccal Film DMT)
VLS-01 is designed to induce a short psychedelic experience, allowing for a total in-clinic treatment of 2-hours, consistent with an established commercial
About this update from Ataibeckley Inc.
[{"type":"text","content":"VLS-01 is designed to induce a short psychedelic experience, allowing for a total in-clinic treatment of 2-hours, consistent with an established commercial paradigm in interventional psychiatryVLS-01 reached peak plasma concentration within 30-45 minutes and was shown to induce a short psychedelic experience, with subjective effects generally resolving within 90-120 minutesVLS-01 demonstrated a favorable safety profile and was well tolerated, with all adverse events classified as either mild or moderate, and most resolving on the day of dosingatai expects to initiate a randomized, double-blind, placebo-controlled Phase 2 study of VLS-01 to assess the efficacy, safety and durability of response of repeated doses in patients with treatment-resistant depression around year-end 2024 NEW YORK and BERLIN, Aug. 13, 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 positive preliminary results from the Phase 1b trial of VLS-01, its proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT) that is applied to the buccal surface. The Phase 1b trial was designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VLS-01 compared to intravenous (IV) DMT. The single center, open-label study enrolled a total of 17 healthy participants, each of whom received a single dose of IV DMT followed by 3 different doses of VLS-01 buccal film—20mg (N=8), 60mg (N=6), 120mg (N=14) or 160mg (N=16)—with a 28-day washout window between administrations. Key takeaways: Peak plasma concentrations (Cmax) were dose-proportional and comparable between the higher VLS-01 buccal film doses (120mg and 160mg) and the 30mg IV DMT dose; peak plasma concentrations were achieved within 30-45 minutes (Tmax).Dose-dependent and robust subjective effects were seen at the 120mg and 160mg doses.In the 120mg dose cohort: 13/14 participants achieved Subjective Intensity Rating Scale (SIRS) scores greater than seven out of ten.Subjective effects, assessed with the SIRS, were fully resolved by 120 minutes.Participants reported that the experience was ‘psychologically meaningful’ with ‘increased levels of self-reflection’. Safety and tolerability: VLS-01 demonstrated a...