OXFORD, UNITED KINGDOM – 03 JUNE 2024 - The first participant has been dosed in a new research study investigating the neurophysiological effects of BPL-003, Beckley Psytech’s novel synthetic intranasal formulation of 5-MeO-DMT (also known as mebufotenin), on the human brain. Beckley Psytech, 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, has provided the funding for this study at Imperial College London via a research grant.
In the single-blind, placebo-controlled study, up to 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 (HD-EEG) scan that measures electrical activity in the brain.
The team hopes the study will reveal novel insights into the effects of intranasal 5-MeO-DMT on brain activity as well as the mechanisms underlying perceived ‘mystical experiences’ and ego dissolution events while under the influence of psychedelics. The research is being overseen by Dr. Christopher Timmermann and Dr David Erritzoe, and is being led by PhD student Tommaso Barba at Imperial College London. Initial results from the study are expected in 2026.
Commenting on the study, Dr Rob Conley, Chief Scientific and Medical Officer at Beckley Psytech, said: "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.”
Dr. Christopher Timmermann, head of the DMT Research Group (part of the Centre for Psychedelic Research at Imperial College London) said: “This study will be the first assessing the effects of 5-MeO-DMT in the human brain and may provide significant advancements in our understanding of consciousness. 5-MeO-DMT is a psychedelic which appears to be particularly effective at inducing states of ego-dissolution and may help us to better understand the relationship between experience, the sense of self, and the brain.”
Tommaso Barba, a PhD student coordinating the study, also said: “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.”
BPL-003 is Beckley Psytech’s lead compound and is currently in Phase II studies for Treatment Resistant Depression (TRD) and Alcohol Use Disorder. Initial results from a Phase IIa 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). This effect was maintained, with 55% of patients in remission from depression at day 29 and 45% of patients in remission from depression at day 85. BPL-003 was also shown to require a short time in clinic with patients assessed as ready for discharge by the Investigators within an average time of less than 2 hours.
A Phase IIb trial of BPL-003 is also currently underway, evaluating the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in TRD patients who are not taking concomitant antidepressants. The Phase IIb study received the U.S Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase IIb clinical trial of a short-acting psychedelic last year and initial results from that study are expected in H2 2024.
For more information please contact: Charlotte Chorley, Communications Lead, at info@beckleypsytech.com
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 formulation currently under investigation in Phase II studies as a potential therapy for 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-stage asset, ELE-101, is a proprietary intravenous formulation of psilocin currently being developed as a potential treatment for Major Depressive Disorder (MDD).
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