• The multi-centre, quadruply-masked Phase IIb study aims to assess the efficacy and safety of different doses of BPL-003 in patients with Treatment Resistant Depression (TRD).
  • The trial is the largest ever efficacy study of 5-MeO-DMT (also known as Mebufotenin) and is taking place at 40 sites across 6 countries, with initial study results expected in 2024.
  • BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device.

Beckley Psytech Ltd, a private, clinical-stage biotechnology company developing rapid-acting, short-duration psychedelic medicines for neuropsychiatric conditions, confirmed today that the first patient had been dosed in its multi-site Phase IIb study (NCT05870540) of BPL-003, a novel synthetic formulation of 5-MeO-DMT (also known as Mebufotenin), for Treatment Resistant Depression (TRD).

The study is taking place at 40 sites across Australia, Germany, Poland, Spain, the United Kingdom and the United States, and is thought to be the largest ever controlled study to investigate 5-MeO-DMT. It follows Beckley Psytech’s receipt of the U.S. Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase IIb study of a short-acting psychedelic compound in February this year.

The randomised, dose-finding trial will evaluate the effects of a medium or high dose of BPL-003, alongside psychological support, against an active placebo in 225 patients with moderate to severe TRD. The study will be quadruply masked, with the patient, investigator, therapist and outcomes assessor all masked to the dose allocation of the subject in order to reduce expectancy bias. Efficacy will be assessed by masked raters using the Montgomery-Asberg Depression Rating Scale (MADRS) at several time points during the trial and psychological support will be given to all patients before, during and after dosing. The team also plan to run an open label extension at some of the trial sites eight weeks after initial dosing to explore BPL-003’s maintenance of effect following a second dose.

The doses for this Phase IIb study were selected after Beckley Psytech’s preclinical and Phase I studies showed BPL-003 to be well-tolerated with a predictable dose-linear pharmacokinetic profile. Medium and high dosages were found to reliably induce profound psychedelic experiences with a rapid onset of psychedelic treatment effects within minutes and the resolution of all perceptual effects within 60-90 minutes.

Beckley Psytech has partnered with Fluence to provide training for the standardised psychological support that will be offered to patients in the trial. Initial results are expected towards the end of 2024 and will be used alongside data from Beckley Psytech’s ongoing Phase IIa study of BPL-003 for TRD to inform the future clinical development of the compound.

“We’re proud to be leading the way in exploring how short-acting psychedelics like 5-MeO-DMT could help address the huge unmet need faced by millions of people living with Treatment Resistant Depression around the world. BPL-003 has so far generated strong safety and pharmacokinetic data, and has been shown to reliably induce short-lasting and profound subjective effects, which correlate with positive therapeutic outcomes. We are optimistic about entering the next stage of clinical development of BPL-003 with this study and we are looking forward to sharing more in the coming months.”

-Cosmo Feilding Mellen, Beckley Psytech’s CEO

“Getting to the first patient being dosed in this study has truly been a global collaboration. We’ve worked with international experts on the study design, trained around 170 therapists from around the world, and are collaborating with 40 highly qualified clinical trial sites in 6 different countries. I would like to take this opportunity to thank everyone who has been involved with our clinical programme so far, as well as the current and future patients who are willing to participate in our trials. We are ever grateful for your time and trust.”

-Dr Rob Conley, Beckley Psytech’s Chief Scientific Officer

Beckley Psytech – www.beckleypsytech.com

Beckley Psytech Ltd is a private, clinical stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by transforming psychedelics into effective and licensed 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.

Original Source