ÎÞÓÇÊÓƵ

ÎÞÓÇÊÓƵ will be presenting data on BPL-003 in a poster presentation at the ECNP 2025 Congress in Amsterdam, The Netherlands. 

Open-label study evaluated a two-dose induction regimen of BPL-003 (8 mg followed by 12 mg two weeks later) in patients with treatment-resistant depression and demonstrated rapid, clinically meaningful and durable antidepressant effects, which are sustained for up to 3 months.

Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose

ÎÞÓÇÊÓƵ Ltd today announces that clinical and micro-phenomenology data from its Phase IIa study of BPL-003 for AUD will be presented at the 87th Annual Scientific Meeting of the US College on Problems of Drug Dependence (CPDD) from 14 - 18 June 2025 in New Orleans.

Strategic combination establishes a market-leading mental health company with a pipeline that includes potentially transformative, rapid-acting psychedelic assets differentiated by their convenient route of administration and short time-in-clinic

It is with profound sadness that we acknowledge the passing of Lady Amanda Feilding, Founder and Director of the Beckley Foundation and Co-Founder of ÎÞÓÇÊÓƵ, aged 82.

Positive results show that a single dose of BPL-003, administered adjunctively to SSRIs, produced a rapid and long-lasting antidepressant effect for up to three months after dosing. BPL-003 was well-tolerated and patients were able to be discharged within an average time of less than two hours. Data from the core, randomised stage of ÎÞÓÇÊÓƵ’s Phase IIb study of BPL-003 for treatment resistant depression is expected in mid-2025.

ÎÞÓÇÊÓƵ will be presenting data from Part 1 of its Phase IIa study of BPL-003 (NCT05660642) for Treatment Resistant Depression (TRD) at the Society of Biological Psychiatry’s (SOBP) Annual Meeting.

The core, quadruple-masked, dose-finding study (NCT05870540) aims to evaluate the efficacy and safety of a single dose of BPL-003 (intranasal 5-MeO-DMT benzoate) in patients with Treatment Resistant Depression (TRD). An open-label extension of the study continues to enrol patients to evaluate the safety and efficacy of a second dose of BPL-003. Topline data from the core, randomised, 8-week study are expected in mid-2025.

A single dose of BPL-003 produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence over the 3-month observation period and the mean percentage of Heavy Drinking Days reducing from 56% in the pre-dose period to 13% 3-months post-dosing. These results come from ÎÞÓÇÊÓƵ’s Phase IIa open-label study (n=12) evaluating BPL-003 in combination with relapse prevention cognitive behavioural therapy for moderate-to-severe Alcohol Use Disorder (AUD). BPL-003 was also shown to be well-tolerated, with no serious or severe adverse events reported. Further results will be presented in 2025 and the team plan to use these findings to evaluate future development options for BPL-003 in substance use disorders.