- 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 Beckley Psytech’s Phase IIb study of BPL-003 for treatment resistant depression is expected in mid-2025.
OXFORD, UNITED KINGDOM – 20 MAY 2025. Beckley Psytech Ltd, a private clinical-stage biopharmaceutical company pioneering the next generation of mental health treatments, today announces positive topline data from Part 2 of its Phase IIa study (NCT05660642) of BPL-003 for treatment resistant depression (TRD).
The findings show that a single dose of BPL-003, when given to patients who were also taking defined selective serotonin reuptake inhibitors (SSRIs), was well-tolerated, with rapid, lasting efficacy of up to three months and an average treatment duration of less than two hours.
The open-label Phase IIa study investigated the safety, efficacy and pharmacokinetics of a single dose of BPL-003 in 12 patients with moderate-to-severe depression who had failed to respond to at least two or more prior treatments of depression and were taking defined SSRIs. Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study.
A single dose of BPL-003 induced rapid and long-lasting antidepressant effects, with a mean MADRS (Montgomery-Asberg Depression Rating Scale) reduction of 18 points from baseline observed the day after dosing, a mean MADRS reduction of 19 points from baseline observed one month after dosing, and a mean MADRS reduction of 18 points from baseline observed three months after dosing.
BPL-003 was shown to be well-tolerated. All adverse events were mild or moderate in severity and there were no serious adverse events (SAEs) reported. Furthermore, acute effects resolved on the day of dosing, with patients deemed dischargeable within an average time of less than two hours. These findings demonstrate the potential of BPL-003 to deliver a scalable single dose treatment model, if approved, and suggest compatibility with the current interventional psychiatric care model established by Spravato®.
The findings are consistent with initial results from Part 1 of the study, which investigated BPL-003 as a monotherapy. Data from that study showed that a single dose of BPL-003 was well-tolerated and produced a rapid and lasting antidepressant effect for up to three months after dosing.
Cosmo Feilding Mellen, Chief Executive Officer at Beckley Psytech, said: “Patients living with treatment resistant depression face limited options, having to choose between treatments that have poor efficacy, undesirable side effects and unfavourable access options. Studies have demonstrated that a single dose of BPL-003 can deliver a rapid and sustained antidepressant effect when administered on its own or alongside SSRIs, and that the compound is well-tolerated with a short treatment duration. These findings highlight BPL-003’s potential as an innovative, differentiated and scalable treatment for depression, and we look forward to sharing results from our Phase IIb study in the coming months.”
Dr Rob Conley, Chief Scientific and Medical Officer at Beckley Psytech, said: “Although a small study, we are very encouraged by these results which validate the safety and efficacy of BPL-003 co-administration with SSRIs. Since conditions like depression are often managed with the use of several interventions, it is important to understand how different treatments interact. We believe that allowing people who wish to stay on SSRIs to be dosed with BPL-003 in clinical studies reduces the risk of withdrawal symptoms, improves accessibility and provides important insight into the effects of co-administration. We are incredibly grateful to the patients and study partners who have helped us reach this important milestone in our clinical development of BPL-003.”
Beckley Psytech is expecting results from the core, randomised, quadruple-masked stage of its Phase IIb study of BPL-003 for TRD in mid-2025. The study, which is thought to be the largest ever controlled clinical study to investigate 5-MeO-DMT and the only blinded Phase IIb study of 5-MeO-DMT in the United States, completed enrolment in March 2025, with 196 patients enrolled across 38 sites in six countries. Data from the study will be used to support end-of-Phase II meetings with regulatory bodies and Phase III planning.
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For more information please contact: Charlotte Chorley, Communications Lead, at info@beckleypsytech.com
About 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 difficult-to-treat 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.
About BPL-003
BPL-003 is Beckley Psytech’s synthetic, proprietary intranasal formulation of 5-MeO-DMT benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short time in the clinic and is being investigated as a potential therapy for treatment resistant depression (TRD) and for 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.
About treatment resistant depression
Depression is a debilitating and life-changing condition affecting nearly 300 million people across the globe, with around 52 million people affected by 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 some studies show that it may affect up to 50% of those living with depression, meaning there is a significant unmet need for more effective treatments.
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