atai Initiates Phase 1b VLS-01 Trial with First Participant Dosed

The Phase 1b clinical trial for a novel antidepressant, VLS-01, developed by atai Life Sciences, has commenced with the dosing of the first participant. This trial is focused on examining the drug's pharmacokinetic and pharmacodynamic properties, as well as its safety and tolerability. VLS-01 is an oral transmucosal film containing N,N-dimethyltryptamine (DMT) and is intended to serve as a quick-acting and long-lasting treatment for individuals with treatment-resistant depression, a condition that impacts nearly 100 million individuals worldwide.

The study is a single-center, open-label design that plans to include 16 healthy volunteers. It will compare the effects of VLS-01 with those of intravenous DMT. Participants will receive a single dose of IV DMT, followed by three different doses of VLS-01, with a 28-day interval between each administration. The primary data from this trial is expected to be released later in 2024.

Florian Brand, CEO and co-founder of atai, expressed enthusiasm for the progress of the trial, highlighting the potential of VLS-01 to provide a brief psychedelic experience that aligns with the current 2-hour clinical treatment model in interventional psychiatry. The drug is designed to offer a more convenient and patient-friendly alternative to IV administration.

Previous trials have led to the optimization of VLS-01's formulation, which now includes taste-masking technology, an added backing layer, and permeability enhancements. The improved formulation is intended to enhance patient experience and pharmacokinetics in anticipation of a possible Phase 2 trial for treatment-resistant depression.

VLS-01 is atai's proprietary DMT formulation, which acts as a partial agonist of the 5-HT 1A/2A/2C receptors and is known for its short-lived psychedelic effects. Clinical data indicate that IV DMT can provide rapid and enduring antidepressant effects for patients with major depressive disorder. The company's goal is to eliminate the need for IV administration and to maximize the therapeutic benefits of a short, in-clinic visit.

atai Life Sciences is a clinical-stage biopharmaceutical firm focused on innovating mental health treatments, addressing a significant unmet need and the lack of innovation in the field. The company is committed to developing new therapeutics for depression, anxiety, addiction, and other mental health issues, aiming to accelerate the development of medicines that can effect significant and lasting behavioral changes in patients.

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