12:26 PM EDT, 08/13/2024 (MT Newswires) -- Atai Life Sciences ( ATAI ) said Tuesday that it plans to proceed with a phase 2 study of VLS-01 in patients with treatment-resistant depression around the end of the year, following positive results from the product candidate's phase 1b trial.
The phase 1b trial was designed to evaluate the relative safety, tolerability, pharmacokinetics, and pharmacodynamics of VLS-01 compared with intravenous N,N-dimethyltryptamine, according to the statement.
The company said VLS-01 reached peak plasma concentration within 30 minutes to 45 minutes and "robust subjective effects" were observed at the 120-milligram and 160-milligram doses.
According to Atai Co-Chief Executive Office Srinivas Rao, the trial's results demonstrated that the 120-milligram dose of VLS-01 struck a balance between safety and psychedelic effect intensity.
The company said the phase 2 trial of VLS-01 will consist of two treatment periods, with top-line data targeted around the end of 2025.