atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that it has dosed the first healthy participant in a Phase 1b trial evaluating its oral formulation of DMT VLS-01, which is being developed for patients with treatment-resistant depression.
The company said that the study is designed to evaluate the relative safety, tolerability, pharmacokinetics and pharmacodynamics of VLS-01 in an oral transmucosal film when compared to intravenous (IV) DMT.
The single-site, open-label study is expected to enroll 16 healthy participants who will each initially receive a single dose of IV DMT followed by three different doses of VLS-01, with a 28-day “washout window” between administrations.
Topline results from the study are expected in the second half of 2024.
atai highlighted that VLS-01 is a short-duration psychedelic, which is delivered through the mouth via a thin dissolvable film. It was designed to offer a more patient and physician-friendly experience when compared to IV delivery.
“Our proprietary oral transmucosal formulation of DMT, VLS-01, is designed to induce a short psychedelic effect to allow for scalability and broad patient access," atai CEO Florian Brand explained.
"VLS-01 is expected to fit into an established interventional psychiatry treatment paradigm of 2 hours in the clinic and is anticipated to offer a more patient and physician-friendly experience compared to IV administration.”
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape.