OXFORD, United Kingdom – 05 MARCH 2025 - Beckley Psytech Ltd, a private biopharmaceutical company developing effective, rapid-acting and accessible medicines for mental health conditions, today announced it has completed enrolment in the core, double-blind stage of its global Phase IIb study of BPL-003 in patients with Treatment Resistant Depression (TRD). BPL-003 is Beckley Psytech’s synthetic, proprietary intranasal formulation of 5-MeO-DMT benzoate, administered via a previously-approved nasal spray device. Topline results from this 8-week core phase of the study are expected in mid-2025.
In the quadruple-masked, dose-finding study, 196 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 were enroled across 38 sites in 6 countries. The study is evaluating the efficacy and safety of a single medium or high dose of BPL-003 against a sub-perceptual dose, with patients followed for eight weeks and efficacy assessed at various timepoints by centralised, blinded raters using the Montgomery-Asberg Depression Rating Scale (MADRS).
An open-label extension of the study continues to enrol patients to evaluate the safety and efficacy of a second high dose of BPL-003 administered eight weeks after the initial dose in the core study.
Data from this Phase IIb study will be used in conjunction with data from Beckley Psytech’s Phase IIa TRD study to support end-of-Phase II meetings with regulatory bodies and Phase III planning in H2 2025. Initial Phase IIa data has already shown 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. If approved, this simple, scalable, single dose treatment model would fit within the existing treatment paradigm that has been successfully established by Spravato®.
Commenting on the news, Beckley Psytech’s CEO, Cosmo Feilding Mellen, said: “We are proud of the continued progress we are making with the clinical development of BPL-003 and we are excited to reach this critical milestone in our Phase IIb study. This is thought to be the largest ever controlled clinical study to investigate 5-MeO-DMT, as well as the first and only blinded Phase II clinical trial of 5-MeO-DMT in the United States. We are encouraged by the promising data from earlier clinical studies of BPL-003 - which have shown that a single dose of BPL-003 can produce rapid, significant and lasting antidepressant effects - and we remain confident in BPL-003’s potential to transform the therapeutic landscape for people living with difficult-to-treat depression. We are thankful to all of the participants and study sites who have made this large, international study possible and we look forward to reporting our topline data from the core phase of the study in mid-2025.”
It is estimated that nearly 300 million people worldwide have depression, with around 52 million people suffering from the condition in Europe and the US combined. Treatment Resistant Depression occurs when an individual does not respond to two or more courses of antidepressants and it is estimated to affect around 33% of those living with depression, or around 100 million people globally. It is a devastating, life-changing condition with a huge unmet need which leaves a profound impact on individuals, their loved ones and wider healthcare systems.
For more information please contact: Charlotte Chorley, Communications Lead, at info@beckleypsytech.com
Beckley Psytech - www.beckleypsytech.com
Beckley Psytech Ltd is a private biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing effective and rapid-acting psychedelic medicines. Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech combines world-leading psychedelic science with extensive drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden neuropsychiatric conditions have on individuals, healthcare systems and society. The company’s lead compound, BPL-003, is a proprietary synthetic 5-MeO-DMT benzoate salt formulation currently under investigation in Phase II studies as a potential therapy for depression and Alcohol Use Disorder. BPL-003 is covered by granted US, UK, European and Chinese 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 currently being developed as a potential treatment for Major Depressive Disorder.
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