OXFORD, United Kingdom – 24 APRIL 2025 - Beckley Psytech Ltd, a private biopharmaceutical company pioneering the next generation of mental health treatments, announced today that it 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 event is taking place in Toronto, Canada, from April 24th - 26th 2025. Dr Fiona Dunbar, Chief Medical Advisor at Beckley Psytech, will deliver a poster presentation titled Rapid, Sustained and Meaningful Antidepressant Effect of Intranasal BPL-003 (5-Methoxy-N,N-Dimethyltryptamine) in Treatment-Resistant Patients on Friday 25th April 2025 from 17:00 - 19:00 EDT.
BPL-003 is Beckley Psytech’s synthetic, proprietary intranasal formulation of 5-MeO-DMT benzoate, administered via a previously-approved nasal spray device. Part 1 of the open-label Phase IIa study investigated the safety, efficacy and pharmacokinetics of a single 10mg dose of BPL-003 in 12 patients with moderate-to-severe depression that had failed to respond to at least two or more prior treatments in the current episode of depression who were not taking concomitant antidepressants. Initial data from that part of the study showed that a single 10 mg dose of BPL-003 can produce a rapid and lasting antidepressant effect, with 55% of patients meeting the criteria for remission (MADRS ≤10) at day 29 and 45% meeting the criteria for remission at day 85. BPL-003 also required a short time in clinic, with patients deemed dischargeable within an average time of less than 2 hours after dosing. Beckley Psytech’s poster presentation at SOBP will provide further detail on these results, as well as additional secondary endpoints.
Commenting on the presentation, Dr. Fiona Dunbar said: “I am looking forward to presenting the promising data from Part 1 of our Phase IIa study of BPL-003 for Treatment Resistant Depression at the Society of Biological Psychiatry’s Annual Meeting. Events like this provide an important opportunity to engage with the scientific and medical community and to add to the growing body of evidence supporting the potential impact of novel treatments like BPL-003 for patients in need."
Topline results from Part 2 of the Phase IIa study, which explored the safety, efficacy and pharmacokinetics of a single dose of BPL-003 in 12 patients with moderate-to-severe depression that had failed to respond to at least two or more prior treatments in the current episode of depression and who were also taking defined SSRIs, are expected in Q2 2025.
For more information please contact: Charlotte Chorley, Communications Lead, at info@beckleypsytech.com
Beckley Psytech - www.beckleypsytech.com
Beckley Psytech Ltd is a private, clinical-stage biopharmaceutical company developing effective, rapid-acting and accessible medicines for people living with mental health conditions. Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech combines cutting-edge science with deep drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden mental health conditions have on individuals, healthcare systems and society. The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt formulation currently under investigation in Phase II studies as a potential therapy for depression and alcohol use disorder (AUD). BPL-003 is covered by granted US, UK and European composition of matter patents, with multiple further claims pending in various jurisdictions. Beckley Psytech’s second clinical-stage asset, ELE-101, is a proprietary intravenous formulation of psilocin benzoate salt currently being developed as a potential treatment for depression.
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