Beckley Psytech announces positive initial data from Phase IIa study of novel 5-MeO-DMT formulation BPL-003 for Treatment Resistant Depression

Beckley Psytech Ltd, the private, clinical-stage biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing effective and rapid-acting psychedelic medicines, today announced positive initial findings from its Phase IIa clinical study (NCT05660642) of BPL-003 for Treatment Resistant Depression (TRD). BPL-003 is Beckley Psytech's novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (Mebufotenin) and is administered intranasally. Initial results show that a single 10mg dose of BPL-003 was well-tolerated with a short treatment duration and rapid, durable efficacy in patients with TRD.

The open-label Phase IIa study investigated the safety, efficacy and pharmacokinetics of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. 12 subjects were dosed, and 11 met the criteria for per-protocol analysis.¹ Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study.

Initial analysis shows that a single dose of BPL-003 induced a rapid antidepressant response in 55% of patients the day after dosing (day 2). Furthermore, these effects were shown to be durable with 55% of patients in remission from depression at day 29 and 45% of patients in remission from depression at day 85. These findings represent the longest-known follow-up of improvement in depression outcomes for a clinical study of 5-MeO-DMT and indicate the durable antidepressant effects of a single administration of BPL-003.

*Response: ?50% reduction in MADRS scores; Remission: MADRS score ?10. MADRS stands for Montgomery?Åsberg Depression Rating Scale.

The results also show that BPL-003 was generally well-tolerated, with convenient nasal administration. 95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings.

Acute effects were resolved and patients were deemed dischargeable within an average time of less than 2 hours. This signals the potential for a shorter treatment duration and reduced resource burden for healthcare systems compared to other psychedelic treatments currently in development. If confirmed in larger registration studies, these findings could support a scalable single dose treatment model that would fit within the existing treatment paradigm that has been successfully established by Spravato®.

An extension of this Phase IIa study is now enrolling patients with TRD who are on stable doses of oral antidepressants in order to assess the safety and efficacy of BPL-003 as an adjunctive treatment.

Commenting on the results, Cosmo Feilding Mellen, Chief Executive Officer at Beckley Psytech, said: "We are delighted to see that a single dose of BPL-003 delivered a rapid and durable antidepressant response in patients with Treatment Resistant Depression. Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity. Less than 15% of patients with Treatment Resistant Depression achieve long-term remission with the current standard of care, and we look forward to further validating the potential of BPL-003 as a treatment option with our ongoing Phase IIb study and subsequent clinical development program."

The initial findings from this Phase IIa study increase confidence in Beckley Psytech's multi-centre Phase IIb study which seeks to further validate BPL-003's safety and efficacy ahead of anticipated end-of-Phase II interactions with regulatory agencies. The Phase IIb study, which is the first, largest and currently only FDA-approved Phase IIb study of 5-MeO-DMT, is evaluating the effects of a medium or high dose of BPL-003 against a sub-perceptual dose in 225 patients with TRD. Efficacy of a single dose alongside psychological support will be assessed using the MADRS scale at several time points during the 8-week blinded follow-up in the trial. Initial results are expected in H2 2024.

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.

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Beckley Psytech - www.beckleypsytech.com

Beckley Psytech Ltd is a private, clinical-stage 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 novel, synthetic 5-MeO-DMT benzoate salt candidate currently under investigation for the treatment of Treatment Resistant Depression (TRD) 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-asset, ELE-101, is a proprietary intravenous formulation of psilocin currently being developed as a potential treatment for Major Depressive Disorder (MDD).

¹ior to data analysis, one subject (from a total of 12 patients) was determined not to meet multiple per protocol eligibility criteria and was excluded from the efficacy analysis.