First Participant Dosed in Study of BPL-003 Neurophysiological Effects

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Investigators have dosed the first participant in a new study investigating the neurophysiological effects of BPL-003, Beckley Psytech’s novel synthetic intranasal formulation of 5-MeO-DMT.¹

In this single-blind, placebo-controlled study, as many as 20 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 scan that measures brain electrical activity.

“5-MeO-DMT is a molecule that has exciting possibilities for the study of consciousness as well as for the development of new psychedelic treatments. The apparent reliability that 5-MeO-DMT has to induce experiences of ego-dissolution may significantly advance our understanding of the brain mechanisms underpinning human experience,” Chris Timmermann, head of DMT Research Group at the Centre for Psychedelic Research, Imperial College London, exclusively told Psychiatric Times. “Our study can also shed light on how these experiences and alterations in brain function may significantly improve mental health.”

BPL-003 is currently under investigation in phase 2 studies for treatment-resistant depression (TRD) and alcohol use disorder. Initial results from a phase 2a study of BPL-003 for TRD in March 2024 showed that a single dose of BPL-003 rapidly induced an antidepressant response in 55% of patients the day after dosing (day 2).² Approximately 55% of patients experienced remission of depressive symptoms at day 29 and 45% of patients experienced remission of depressive symptoms at day 85, demonstrating the longevity of effect. BPL-003 also takes effect quickly in the clinic, with patients assessed as ready for discharge by the investigators in 2 hours or less, on average.

Investigators hope this study will illuminate the effects of intranasal 5-MeO-DMT on brain activity as well as the mechanisms underlying ‘mystical experiences’ with the use of psychedelics. Initial results from the study are expected in 2026.

“It is particularly exciting to begin the dosing phase in this important study. 5-MeO-DMT is among the most potent psychedelics, but its effects on the brain are still not well understood. Our research is poised to deliver substantial advancements in our comprehension of these compounds and we hope it will bring further advancements on the link between psychedelics and the dissolution of our usual sense of self,” said Tommaso Barba, a PhD student coordinating the study.¹

A phase 2b trial of BPL-003 is also underway, with investigators evaluating the effects of a medium or high dose of BPL-003 against a subperceptual dose in patients with TRD not taking concomitant antidepressants. The phase 2b study received the US Food and Drug Administration’s first ever Investigational New Drug approval for a phase 2b clinical trial of a short-acting psychedelic last year. Initial results from this study are expected later in 2024.

“We are very proud to be supporting world-leading researchers at Imperial College London to learn more about how our lead compound, BPL-003, works in the human brain. Literature suggests an association between intensity of psychedelic experiences and positive treatment effects, so we are keen to explore further and hopefully uncover new insights that we can use to inform our ongoing clinical studies of BPL-003 for treatment-resistant depression and alcohol use disorder,” said Rob Conley, chief scientific and medical officer at Beckley Psytech.¹

References

1. First participant dosed in research study investigating the effects of BPL-003, a novel formulation of 5-MeO-DMT, on the human brain. News release. June 3, 2024. https://www.beckleypsytech.com/posts/first-participant-dosed-in-research-study-investigating-effects-of-5-meo-dmt-on-human-brain

2. Kuntz L. BPL-003: rapid, durable treatment for TRD sees positive phase 2 results. Psychiatric Times. March 27, 2024. https://www.psychiatrictimes.com/view/bpl-003-rapid-durable-treatment-for-trd-sees-positive-phase-2-results