atai Life Sciences announced that the first patient has been dosed in Part 2 of Beckley Psytech?s Phase 2a study, evaluating BPL-003 (intranasal 5-MeO-DMT) in patients living with Treatment Resistant Depression (TRD). In Part 2 of this open-label Phase 2a study (NCT05660642), patients with moderate-to-severe TRD who are on a stable course of certain oral selective serotonin reuptake inhibitor (SSRI) antidepressants will receive a single dose of BPL-003 alongside psychological support to explore the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BPL-003 as an adjunctive therapy to SSRIs. Patients will be followed for 12 weeks post-dosing.

Initial results are expected in first half of 2025. Part 1 of the Phase 2a study investigating BPL-003 for TRD assessed a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. Initial data showed that a single dose of BPL-003 induced a rapid antidepressant response in 55% of patients on the day after dosing.

The antidepressant effect was durable, with a 55% response rate maintained at week 4, which continued to week 12. There were 55% of patients in remission at week 4 and 45% in remission at week 12. BPL-003 was also shown to require a short time in clinic with acute effects resolving on average in less than two hours, highlighting the potential of BPL-003 to deliver a scalable single dose treatment model that could fit within the existing Spravato two-hour treatment paradigm.

The BPL-003 Phase 2b study is currently underway, evaluating the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in TRD patients (NCT05870540). Initial results from that study are expected in second half of 2024. Beckley Psytech is a private clinical-stage biopharmaceutical company developing BPL-003, which is a novel, patent-protected, synthetic benzoate salt formulation of 5-MeO-DMT which is delivered intranasally.

It is a short-duration psychedelic compound that binds to a variety of serotonergic receptors. Epidemiological surveys and observational studies have reported that 5-MeO-DMT is associated with improvements in mood, anxiety, reduced stress, increased life satisfaction and mindfulness. 5-MeO-DMT has been reported to produce mystical experiences with comparative intensity as seen with high doses of psilocybin but has a significantly shorter duration of effect.

In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization.