atai Life Sciences, trading under NASDAQ:ATAI and ETR:9VC, recently announced the encouraging findings from a study conducted by its investee, Beckley Psytech, on a pioneering DMT formulation, BPL-003, for individuals struggling with treatment-resistant depression.
During this open-label Phase 2a investigation, a select group of patients received a single dose of BPL-003. This novel, synthetic formulation of 5-MeO-DMT, known as mebufotenin, presented in the form of a benzoate salt, was administered intranasally alongside psychological support. Remarkably, 55% of participants exhibited a rapid antidepressant response merely a day following the treatment.
The study focused on 12 individuals diagnosed with moderate-to-severe depression that had not responded to traditional treatments. These participants were not on any antidepressant medications during the study period.
Highlighting the study’s findings, atai Life Sciences noted an impressive remission rate among the participants: 55% at the four-week mark and 45% sustaining remission up to twelve weeks post-treatment. This duration of follow-up, tracking depression outcomes, is reportedly the longest ever recorded in a clinical study involving 5-MeO-DMT.
The effectiveness of BPL-003 was gauged using the Montgomery–Åsberg Depression Rating Scale (MADRS), a recognized tool for assessing the severity of depressive episodes. The safety profile of the drug was also a significant consideration, with reports confirming it was well-tolerated and devoid of any serious adverse effects. Notably, the acute effects of the drug subsided on average in less than two hours, suggesting BPL-003 could potentially streamline the treatment process in clinical settings compared to other psychedelic therapies under development.
Florian Brand, CEO of atai Life Sciences, expressed enthusiasm over the study’s outcomes, particularly the durability of BPL-003’s antidepressant effects from just a single administration. Brand emphasized the potential for BPL-003 to integrate into a two-hour in-clinic treatment model, a framework successfully established by Spravato.
Building on these promising results, an extension of the Phase 2a study is currently recruiting individuals with treatment-resistant depression who are on stable antidepressant regimens. This extension aims to further evaluate the safety and efficacy of BPL-003 when used in conjunction with standard antidepressant treatments.
Moreover, a comprehensive Phase 2b study is in progress, exploring the impact of a single administration of BPL-003 at doses of 12mg or 8mg compared to a sub-perceptual dose of 0.3mg. This study involves 225 patients with treatment-resistant depression, with the anticipation of topline results by the second half of 2024.
Brand conveyed optimism about the ongoing research, highlighting the Phase 2a study’s “highly encouraging” data as the scientific community eagerly awaits the detailed findings from the forthcoming Phase 2b trial.
In a strategic move, atai Life Sciences secured a 35.5% ownership stake in Beckley Psytech, a privately held clinical-stage biopharmaceutical company, in January 2024, further cementing its commitment to pioneering advancements in the treatment of depression.