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atai Life Sciences Announces Positive Preliminary Results from Phase 1b Trial of VLS-01 (Buccal Film DMT)
atai Life Sciences (NASDAQ: ATAI)announced positive preliminary results from its Phase 1b trial of VLS-01, a proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT). The trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of VLS-01 compared to intravenous DMT in healthy participants.
Key findings include:
Dose-proportional peak plasma concentrations achieved within 30-45 minutes
Robust subjective effects at 120mg and 160mg doses
Favorable safety profile with mild to moderate adverse events
Short psychedelic experience resolving within 90-120 minutes
Based on these results, atai plans to initiate a Phase 2 study in patients with treatment-resistant depression around year-end 2024, with topline data expected around year-end 2025.
Key findings include:
Dose-proportional peak plasma concentrations achieved within 30-45 minutes
Robust subjective effects at 120mg and 160mg doses
Favorable safety profile with mild to moderate adverse events
Short psychedelic experience resolving within 90-120 minutes
Based on these results, atai plans to initiate a Phase 2 study in patients with treatment-resistant depression around year-end 2024, with topline data expected around year-end 2025.
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