atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that Beckley Psytech has dosed the first patient in the second part of its Phase 2a study of its novel intranasal 5-MeO-MDT drug candidate BPL-003 in treatment-resistant depression.
Initial results from the first part of the study unveiled in March showed that a single dose of BPL-003 was safe and well-tolerated and had a “rapid and durable” antidepressant effect which lasted up to 12 weeks.
The second part of the study will evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of BPL-003 as an adjunct therapy in patients currently taking certain oral selective serotonin reuptake inhibitor (SSRI) antidepressants.
Patients will receive a single dose of BPL-003 alongside psychological support.
They will be followed up for 12 weeks after dosing, with initial results expected in the second half of 2025.
atai CEO Florian Brand highlighted that many clinical trials investigating psychedelics require patients to stop taking their existing antidepressant medication.
“The findings from this adjunctive therapy part of the BPL-003 Phase 2a study will help to inform whether BPL-003 could be a safe and effective therapy in combination with SSRIs, which could allow for broader patient access, should BPL-003 reach approval,” Brand said.
atai in January 2024 obtained a 35.5% ownership stake in Beckley Psytech, a private clinical-stage biopharmaceutical company.