Atai Life Sciences N.V. (NASDAQ: ATAI), which is developing VLS-01, a form of DMT for the treatment -resistant depression (TRD), announced today the dosing of the first subject in their Phase 1 SAD trial of VLS-01.
The trial is a randomized, double-blind, placebo-controlled study designed to evaluate the relative bioavailability of buccal versus IV formulations, the safety, and tolerability of VLS-01 administered by both routes, as well as pharmacodynamics of DMT using qEEG and other measures. Buccal VLS-01 is formulated to provide a psychedelic experience lasting 30 to 45 minutes, thus potentially allowing for a shorter clinic visit compared to many other psychedelic compounds that may require a patient to be monitored for four or more hours.
A trial includes the companion use of atai’s IDEA-1 digital therapeutic app to provide contextual “(mind)set-and-setting” prior to dosing, as well as behavioral activation therapy, group therap, and patient monitoring post-dosing. These behavioral assessments, in conjunction with the pharmacokinetic and safety readouts, are expected to inform the design of and doses tested in future Phase 2 clinical trials of VLS-01.
Srinivas Rao, Chief Scientific Officer commented on the trial:
“Exploring novel approaches to drug delivery can potentially simplify in-clinic administration and allow greater pharmacokinetic control of the psychedelic experience and its overall duration of hallucinogenic effects. We’re pleased to see this trial move forward as we establish the safety and tolerability of our compound.”
Glenn Short, SVP, Early Development also commented:
“A practical approach to DMT administration would give people access not only to the pharmacological benefits of DMT but will also afford them time to explore the personal insights from their experiences with therapists…given the scale of the depression crisis, the impact on patients and families could be enormous.”
atai anticipates Phase 1 topline results in H1 2023.
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