ATAI - Atai begins dosing in phase 1 trial of synthetic DMT for treatment-resistant depression

Atai Life Sciences ( NASDAQ: ATAI ) said it dosed the first person in a phase 1 trial of VLS-01 for treatment-resistant depression (TRD).

VLS-01 is a synthetic form of N,N-dimethyltryptamine (DMT) being developed for TRD, the company said in an Oct. 5 press release.

DMT is a type of psychedelic.

The trial is placebo-controlled study to evaluate the relative bioavailability of buccal (mouth/cheek) versus IV formulations, safety and tolerability of VLS-01 administered by both routes, and pharmacodynamics of DMT using qEEG and other measures, the company noted.

"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," said Glenn Short, senior vice president, early development of atai.

The company noted that 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.

Atai added that the trial includes the companion use of atai's IDEA-1 digital therapeutic app to provide contextual "(mind)set-and-setting" prior to dosing, and behavioral activation therapy, group therapy, and patient monitoring post-dosing.

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