OXFORD, UNITED KINGDOM - 17 APRIL 2024. 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 the publication of a new paper in The Journal of Psychopharmacology which demonstrates the safety, tolerability and rapid-acting subjective effects of BPL-003, Beckley Psytech’s novel, synthetic, intranasal benzoate salt formulation of 5-MeO-DMT (also known as mebufotenin).
These findings come from Beckley Psytech’s Phase I trial of BPL-003, which was completed in November 2022. The double-blind, placebo-controlled, single ascending dose study explored the safety, tolerability, pharmacokinetics and pharmacodynamics of BPL-003 in combination with psychological support in 44 psychedelic-naïve healthy volunteers. In the study, participants across 7 cohorts were given either a single dose of BPL-003 between 1 mg to 12 mg or a placebo.
The peer-reviewed paper shows that BPL-003 was safe and well-tolerated in the study with no serious or severe adverse events reported. BPL-003 was rapidly absorbed and eliminated, with 5‑MeO-DMT systemic exposure increasing approximately dose‑proportionally. There was a reliable onset of psychedelic effect within minutes and consciousness-altering effects were resolved in less than 2 hours. These findings indicate the potential of BPL-003 to deliver a shorter treatment time and reduced resource burden compared to other psychedelic treatments 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®.
The intensity of the psychedelic experience was shown to correlate with exposure to the compound, with scores of the Mystical Experience Questionnaire (MEQ-30) and Ego Dissolution Inventory (EDI) increasing proportionally with the dosage of BPL-003. Sixty percent of participants had a ‘complete mystical experience’, which is defined as reaching or exceeding a score of 3 on all four subdomains of the MEQ-30 scale, at 10 mg and 12 mg doses of BPL-003. Notably, 87% of participants who received BPL-003 said they would accept the same or higher dose again, with 100% of participants who received the highest (12 mg) dose stating they would accept the same or higher dose again.
Commenting on the publication, Cosmo Feilding Mellen, Chief Executive Officer at Beckley Psytech, said: “We’re pleased to see the results of our Phase I study of BPL-003 published in this well-regarded and peer-reviewed journal. The findings show that BPL-003 has a good safety profile and is well-tolerated, with a highly controllable delivery action and a reliable induction of psychedelic experiences. The rapid-acting, short-duration formulation also indicates that BPL-003 could be an accessible and effective treatment, and we are looking forward to assessing this further in our ongoing Phase II studies of BPL-003 for Treatment Resistant Depression and Alcohol Use Disorder. I would like to take this opportunity to thank the participants in this study, as well as our trial partners, for their willingness to take part in this exciting and important scientific endeavour.”
BPL-003 is currently under investigation in Phase IIa studies as a potential treatment for Alcohol Use Disorder (NCT05674929) and Treatment Resistant Depression (NCT05660642). It is also being explored in a multi-site Phase IIb study (NCT05870540) for Treatment Resistant Depression (TRD). 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 is currently thought to be the largest ever study to investigate 5-MeO-DMT in a clinical setting. The trial is 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. Initial results from that study are expected in H2 2024.
For more information, or to request a free copy of the paper, please contact: Charlotte Chorley, Communications Lead, at info@beckleypsytech.com
About 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).
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