atai Life Sciences N.V. (Nasdaq: ATAI), which is developing VLS-01, a form of N,N-dimethyltryptamine (DMT) for the treatment of 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.

The 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 therapy, 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.

An estimated 100 million people live with TRD globally – or a third of people with depression – who are undertreated or unresponsive to available treatment options. In addition to its impact on patients, families, and caregivers, TRD significantly burdens healthcare systems and payers. Direct medical costs for TRD patients are estimated to be two times higher than for non-TRD major depressive disorder (MDD) patients, with an average of twice the number of inpatient visits and hospital stays that are over one-third longer.

“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.”

Srinivas Rao, Chief Scientific Officer of atai Life Sciences

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 Life Sciences. “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.

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.

atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life.