atai Life Sciences Announces Dosing of First Patient in Part 2 of Beckley Psytech’s Phase 2a Study Exploring BPL-003 Adjunctive to SSRIs in Patients with Treatment Resistant Depression

• The BPL-003 Phase 2a trial is an open-label study investigating BPL-003 as both monotherapy and adjunctive to SSRIs in patients with Treatment Resistant Depression.
• Initial results from the recently completed monotherapy Part 1 of the study were shared in March 2024, and showed that a single dose of BPL-003 was safe and well-tolerated, with a rapid and durable antidepressant effect lasting up to 12-weeks post-dose.
• Part 2 of the study will investigate a single dose of BPL-003 in patients who are currently on a course of SSRI antidepressants.
• The first patient has been dosed in Part 2 of the study and initial results are expected in H1 2025.

NEW YORK and BERLIN, April 24, 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 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 H1 2025.

Commenting on Part 2 of the trial, Florian Brand, CEO and Co-Founder of atai, said: “Many clinical trials investigating psychedelics require patients to discontinue 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.”

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 response¹ 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 remission² 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.