atai Life Sciences (NASDAQ:ATAI, ETR:9VC) said it is pleased that the results of investee Beckley Psytech's safety study of its synthetic DMT formulation have been published in The Journal of Psychopharmacology.
The study investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of BPL-003, a novel, synthetic, intranasal benzoate salt formulation of 5-MeO-DMT, in combination with psychological support in 44 healthy volunteers who were split into seven cohorts and given a single dose of BPL-003 ranging from 1 mg to 12 mg or a placebo.
BPL-003 was shown to be safe and well tolerated, with no serious or severe adverse events reported.
Psychedelic effects occurred within minutes and were resolved in less than two hours which atai believes, if confirmed in larger studies, means the single-dose treatment model could be scaled up within existing treatment infrastructure.
It highlighted that 87% of patients who received BPL-003 said they would accept the same or higher dose again and 100% of the participants who received the highest dose, 12 mg, said they would accept the same or higher dose again.
“We are pleased by the publication of the BPL-003 Phase 1 data in The Journal of Psychopharmacology, a well-regarded, peer-reviewed journal,” atai CEO Florian Brand said in a statement.
“Consistent with the initial Phase 2a data reported recently, the Phase 1 results showed that BPL-003 was safe and well-tolerated and underscore its potential as a scalable interventional treatment requiring two hours or less in the clinic, in line with the treatment paradigm successfully established by Spravato.”
BLP-003 is being evaluated in Phase 2a studies as a potential treatment for alcohol use disorder and treatment-resistant depression, atai highlighted.
It is also under investigation in a Phase 2b study for treatment-resistant depression, with initial results expected from this study in the second half of 2024.
In January 2024, atai made a strategic investment in Beckley Pystech resulting in a 35.5% ownership stake in the company and a right of first negotiation for BPL-003, among other terms.