Beckley Psytech announced that it will be presenting data on BPL-003, a novel synthetic intranasal formulation of 5-MeO-DMT benzoate, in two poster presentations at the ECNP 2024 Congress in Milan, Italy on Sunday 22nd and Monday 23rd September. BPL-003 is Beckley Psytech’s novel synthetic intranasal formulation of 5-MeO-DMT benzoate and is currently under investigation in Phase II studies as a potential therapy for Treatment Resistant Depression and Alcohol Use Disorder. BPL-003 has been specifically designed to overcome some of the challenges of first-generation psychedelics and existing mental health treatments and produce rapid and lasting treatment effects within a short time in clinic of less than 2 hours. 

Dr. Hershberg is Co-Founder, President, Chief Executive Officer and Chairman of the Board of Directors at Hillevax Inc., a NASDAQ-listed biopharmaceutical company focused on the development and commercialisation of novel vaccine candidates. He is also a Venture Partner with Frazier Healthcare Partners and has been working with Frazier and its portfolio companies as an Entrepreneur-in-Residence, Senior Advisor, and executive for the last 14 years. Alongside news of Dr Hershberg’s appointment, Beckley Psytech also announced that Lady Amanda Feilding, Co-Founder of Beckley Psytech, will be stepping down from the Board in order to focus her work as Executive Director of The Beckley Foundation. She will continue supporting the Beckley Psytech team as a senior scientific and strategic advisor. 

The Phase IIa trial is an open-label study investigating ELE-101 as a potential new treatment for Major Depressive Disorder (MDD), commonly known as depression. The study will evaluate the safety, tolerability, subjective effects and efficacy of a single intravenous dose of ELE-101 in patients with depression. The dose for the study was selected using preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data from Beckley Psytech’s Phase I double-blind, placebo-controlled, randomised study of ELE-101 in healthy participants. That data showed that ELE-101 was well-tolerated with a dose-proportional pharmacokinetic profile and reliable induction of high-intensity, short-duration psychedelic experiences.

Beckley Psytech and PsyPAN have published a new Impact Report which shares novel insights from psychedelic clinical trial participants. The report highlights the desire for post-trial support and introduces a peer support pilot program for participants. Beckley Psytech has given PsyPAN an unrestricted grant to initiate the 12-month pilot program aimed at supporting trial participants in the UK.

The study is the first of its kind to assess the effects of 5-MeO-DMT in the human brain and will investigate the neurophysiological effects of BPL-003, Beckley Psytech’s novel synthetic intranasal formulation of the psychedelic 5-MeO-DMT. In the study, healthy volunteers will be given both placebo and a 12 mg dose of BPL-003 on separate study visits over a period of 1 month while undergoing a high-density electroencephalogram (HD-EEG) scan to measure the electrical activity in the brain in order to better understand how 5-MeO-DMT elicits its profound consciousness-altering effects. The trial is being overseen by Dr. Christopher Timmermann and Dr David Errtizoe from the Centre for Psychedelic Research at Imperial College London and is funded through a research grant from Beckley Psytech. Initial results are expected in 2026.

The Phase IIa trial is a two-part, open-label study investigating the safety, tolerability and pharmacodynamics of BPL-003, Beckley Psytech’s novel, synthetic intranasal formulation of 5-MeO-DMT, in patients with Treatment Resistant Depression (TRD). Part 1 of the study was in patients who were not taking antidepressants. Initial results from that part, shared in March 2024, showed that a single dose of BPL-003 was safe and well-tolerated, with a rapid and durable antidepressant effect lasting up to 85 days post-dose. The first patient has now been dosed in Part 2 of the study, which will assess a single dose administration of BPL-003 in TRD patients who are also taking SSRI antidepressants in order to understand the effects of BPL-003 as an adjunctive therapy to SSRIs. Initial results from Part 2 of this study are expected in H1 2025.

BPL-003 is Beckley Psytech’s novel patent-protected benzoate salt formulation of 5-MeO-DMT that is administered intranasally. The Phase I, placebo-controlled, single ascending dose study was completed in November 2022 and explored the safety, tolerability, pharmacokinetics, and pharmacodynamics of BPL-003 alongside psychological support in healthy participants. BPL-003 was shown to be safe and well-tolerated in the study with a predictable pharmacokinetic profile and a reliable induction of psychedelic experiences with single doses of up to 12 mg in healthy participants. Psychedelic experiences correlated to 5-MeO-DMT exposure and had a rapid onset and short duration, with consciousness-altering effects resolving in less than 2 hours.

Initial results from Beckley Psytech's Phase IIa study of BPL-003 for Treatment Resistant Depression (TRD) 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 initial findings 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.

Strategic investment in Beckley Psytech reinforces atai’s position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelic candidates. Multiple clinical readouts are anticipated from this investment in Beckley Psytech within the next 12 months, including a Phase IIb readout of BPL-003 in Treatment Resistant Depression in 2H24. There are also multiple anticipated synergies expected through collaborating on digital therapeutics, commercial and market access activities in preparation for potential future commercialization.

BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device. 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 thought to be 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.