atai life sciences reveals positive clinical trial results and discusses FDA ruling on MDMA
Published: 07:50 14 Aug 2024 EDT
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) co-founder and co-CEO Dr Srinivas Rao takes Proactive's Stephen Gunnion through the positive results from the Phase 1b trial of VLS-01, an oral thin film formulation of DMT.
VLS-01 is being developed for treatment resistant depression, a condition that impacts the lives of an estimated 100 million people globally. Srinivas emphasizes the potential of VLS-01 as a best-in-class treatment option, with excellent tolerability, patient-friendly administration and a short 2 hour in-clinic treatment time. The trial revealed that the formulation exceeded expectations, particularly in terms of pharmacokinetics, with results comparable to intravenous administration.
Rao noted that the next steps include advancing the 120mg dose into a robust Phase 2 trial for treatment-resistant depression, with results expected by the end of next year. He also addressed recent FDA decisions regarding MDMA and how atai's approach in trial design avoids similar pitfalls.
Beyond VLS-01, Rao highlighted that the company is progressing its clinical development plans for EMP-01, which is oral R-MDMA, with a Phase 2 trial for social anxiety disorder set to initiate by the end of the year.
