atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression

- A single dose of BPL-003 demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12

- 55% of patients achieved a clinical response on the day after dosing and this rate of response was maintained at week 4 and week 12

- BPL-003 showed a good safety profile and was well-tolerated with no serious adverse events reported

- Acute effects resolved on average in less than two hours, highlighting BPL-003’s potential to fit within the Spravato two hour in-clinic treatment paradigm

- Phase 2b study of BPL-003 in 225 TRD patients is underway with top-line results expected in H2 2024

NEW YORK and BERLIN, March 27, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced positive initial results from Beckley Psytech’s Phase 2a open label study of BPL-003 in Treatment Resistant Depression (TRD), a condition that affects approximately 100 million people worldwide.

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

The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. 12 subjects were dosed, and 11 met the criteria for per-protocol analysis¹. Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study. Efficacy was assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS).

Initial analysis showed that a single dose of BPL-003 induced a rapid antidepressant response² 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 remission³ at week 4 and 45% in remission at week 12. These findings represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.