atai Life Sciences Announces Positive Preliminary Results from Phase 1b Trial of VLS-01 (Buccal Film DMT)

In This Article:

atai Life Sciences
atai Life Sciences
  • 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 psychiatry

  • VLS-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 minutes

  • VLS-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 dosing

  • atai 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 favorable safety profile and was well tolerated, with all adverse events classified as either mild or moderate, and most resolving on the day of dosing.

  • The most common treatment-emergent adverse events (TEAEs) were headache, dissociation, euphoric mood and nausea.

  • No TEAEs of vomiting or local irritation were noted at doses of 120mg or lower, and only 1 subject out of 14 (7%) reported nausea at the 120mg dose.

  • There were no observed adverse events related to blood pressure, heart rate or suicidality.