atai Life Sciences (NASDAQ:ATAI, ETR:9VC) chief scientific officer Dr Srinivas Rao discusses the company’s development candidate VLS-01, aimed at treating treatment-resistant depression, with Proactive’s Stephen Gunnion.
Rao explained that VLS-01 is a formulation of DMT, the active component in ayahuasca, known for its short-duration psychedelic effects. The innovation lies in its delivery method, an oral transmucosal film, resembling a Listerine strip, which dissolves inside the mouth over 20 minutes, providing a patient-friendly alternative to intravenous administration. Rao said this approach is designed to enhance the patient and healthcare provider experience, especially in settings not equipped for IV treatments.
The ongoing Phase 1B trial seeks to confirm VLS-01’s safety, tolerability, pharmacokinetics (PK), and pharmacodynamics, aiming for a psychoactive effect lasting 30-45 minutes with patients returning to baseline within two hours post-administration. Rao said this trial format follows the US treatment paradigm established by Spravato (esketamine) for depression. The trial will involve 16 healthy volunteers to assess the drug’s impact, setting a baseline with intravenous DMT before testing up to three oral doses of VLSI-01.
Initial results are expected in the second half of the year, with plans to proceed to Phase 2 trials involving patients with treatment-resistant depression to evaluate the compound’s efficacy further.