atai's Phase 1 Synthetic DMT-Based Drug Clinical Trial Begins Patient Dosing

Clinical-stage biopharma company atai Life Sciences N.V. ATAI has commenced dosing volunteers for its ongoing Phase 1 clinical study investigating its proprietary DMT-based VLS-01 for treatment-resistant depression (TRD). 

The randomized, double-blind, placebo-controlled, single-ascending dose (SAD) trial aims to compare the bioavailability of oral and IV formulations, the safety and tolerability of VLS-01 administered by both routes, and the pharmacodynamics of DMT through qEEG and other measures. 

As a distinctive asset, the oral version of VLS-01 is designed to induce a psychedelic experience of 30 to 45 minutes, potentially allowing for a shorter clinic visit compared to other psychedelic compounds that may require a longer patient monitoring period. 

The trial is set to combine drug administration with atai’s digital therapeutic app, IDEA-1, to provide “(mind)set-and-setting” before dosing as well as behavioral and group therapy and individual monitoring after dosing. 

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Topline results of this Phase 1 trial would be available in the first half of 2023. The behavioral assessments, together with the PK and safety outcomes, are expected to inform the design of and doses tested in future Phase 2 clinical trials of VLS-01. 

Srinivas Rao, atai’s chief scientific officer said that 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." 

For instance, facilitating that patients attend follow-up psychotherapy sessions later on the same day they receive the drug administration, therefore “making treatment more convenient and accessible while increasing integration.” 

atai’s early development senior VP Glenn Short added that a “practical approach” to DMT administration would expand its pharmacological benefits to people but also give them time “to explore the personal insights from their experiences with therapists,” in view of the global crisis of depression and current undertreatment and unresponsiveness rates to available treatments.

Photo courtesy of CDC on Pexels and Jynto on Wikimedia Commons.