atai Life Sciences Advances VLS-01, A Novel DMT-Based Treatment

LOS ANGELES- atai Life Sciences a biotechnology company specializing in mental health treatments, is making strides in the development of a groundbreaking approach to treating treatment-resistant depression. Dr. Srinivas Rao, the Chief Scientific Officer, recently shed light on the company’s promising development candidate, VLS-01, in a discussion with Proactive’s Stephen Gunnion.

VLS-01 is a novel formulation of DMT, the psychoactive molecule in ayahuasca, tailored to address the challenges of treatment-resistant depression. Rao emphasized the innovative delivery mechanism of VLS-01 — an oral transmucosal film, similar to a dissolvable strip akin to Listerine, designed to dissolve in the mouth over 20 minutes. This method represents a significant leap forward, offering a patient-friendly alternative to the more invasive intravenous (IV) administration. The oral transmucosal film aims to enhance both the patient and healthcare provider experience, particularly in settings that lack the infrastructure for IV treatments.

The company is currently conducting a Phase 1B clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of VLS-01. The trial aims to establish a psychoactive effect duration of 30-45 minutes, with patients expected to return to their baseline state within two hours post-administration. This trial structure mirrors the U.S. treatment model initiated by Spravato (esketamine) for depression, setting a precedent for the therapeutic use of psychoactive compounds in mental health treatments.

The Phase 1B trial will involve 16 healthy volunteers and will commence with a baseline assessment using intravenous DMT before progressing to up to three oral doses of VLS-01. This step is crucial in understanding the drug’s impact and fine-tuning its dosage for maximum efficacy with minimal side effects.

Initial results from the trial are anticipated in the second half of the year. Should these outcomes prove favorable, atai Life Sciences plans to advance VLS-01 into Phase 2 trials. The subsequent phase will involve patients with treatment-resistant depression, focusing on further evaluating the compound’s efficacy in alleviating depressive symptoms in this challenging patient demographic.

atai Life Sciences’ work on VLS-01 marks a pivotal moment in the quest for more effective depression treatments, particularly for those who have found little relief from existing therapies. The company’s innovative approach, centered around the unique properties of DMT and a novel delivery system, offers hope for significant advancements in mental health care, potentially transforming the lives of millions suffering from treatment-resistant depression.