Atai Life: Beckley Psytech's Phase 2a Trial Of BPL-003 Positive In Treatment Resistant Depression

(RTTNews) - atai Life Sciences (ATAI), a clinical-stage biopharmaceutical company focused on mental health disorders, announced Wednesday positive initial results from Beckley Psytech's Phase 2a open label study of BPL-003 in Treatment Resistant Depression or TRD.

In pre-market activity on the Nasdaq, atai shares were gaining around 4.1 percent to trade at $1.80.

The new data suggest that BPL-003 could offer a shorter in-clinic treatment time when compared to other psychedelic treatments currently in development.

The company noted that a Part 2 extension of this Phase 2a open label study is now enrolling patients with TRD who are on stable doses of oral antidepressants to assess the safety and efficacy of BPL-003 co-administration.

Private clinical-stage biopharmaceutical company Beckley Psytech, in which atai holds a 35.5% ownership stake, is developing BPL-003, which is 5-MeO-DMT, a short-duration psychedelic tryptamine that binds to a variety of serotonergic receptors.

BPL-003 is a novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (mebufotenin) administered intranasally.

In the open-label Phase 2a study, the safety, tolerability and efficacy of a single 10mg dose of BPL-003 was investigated alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants.

Initial results of the trial demonstrated that a single 10mg dose of BPL-003 was well-tolerated and resulted in a rapid onset and durable antidepressant effect in patients living with TRD.

Adverse events were predominantly mild or moderate and the most common AEs were nasal discomfort, headaches, nausea and vomiting, broadly consistent with Phase 1 findings. No serious AEs were reported.

Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences said, "The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year. With around half of TRD patients in remission three months after just a single dose of BPL-003 in this study, we are particularly excited about its antidepressant durability potential. The results indicate that BPL-003 could offer a scalable, single-dose administration within the two hour in-clinic treatment paradigm successfully established by Spravato."

A randomized, quadruple-masked, controlled Phase 2b study of BPL-003 is currently underway (NCT05870540). The study is investigating the effects of a single 12mg or 8mg dose of BPL-003 against a sub-perceptual dose of 0.3mg in 225 patients with TRD.

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