Beckley Psytech Announces First Participant Dosed in Phase I Trial of ELE-101, A Novel Intravenous Formulation of Psilocin

• Beckley Psytech has dosed the first participant in their Phase I single-ascending dose (SAD) study of ELE-101, with top-line results expected in H1 2023.
• ELE-101 is a patent-protected, next-generation formulation of psilocin, the active metabolite of psilocybin, under clinical development for depression.
• ELE-101 is the second clinical-stage psychedelic compound in Beckley Psytech’s portfolio alongside BPL-003, the company’s lead candidate for upcoming MHRA-approved Phase IIa studies in depression and Alcohol Use Disorder (AUD).

OXFORD, England--(BUSINESS WIRE)--Beckley Psytech, a clinical-stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, today announced that the first participant has been dosed in its Phase I clinical trial (NCT05434156) of ELE-101, a novel, short-acting psychedelic compound which is intended to serve as a possible treatment for depression.

The trial is a double-blind, randomised, placebo-controlled study designed to assess the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) and subjective drug intensity (SDI) of single ascending intravenous doses of ELE-101 in up to 60 healthy adult participants. Full results of the study are expected in H1 2023, and blinded data will be used to help design the Phase IIa study, with initiation also planned for H1 2023.

ELE-101 was added to Beckley Psytech’s portfolio following the acquisition of Eleusis Therapeutics Limited in October 2022. The team is confident that the proprietary intravenous formulation of psilocin, the active metabolite of psilocybin, has the potential to address some of the observed limitations of oral psilocybin - such as long duration of action and variability in patients’ responses - and is designed to deliver a shorter, more consistent and more controllable experience in patients, with fewer side effects.

Commenting on the initiation of the Phase I study, Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “This is an important milestone for Beckley Psytech and demonstrates our commitment to positively disrupt the way depression and other neuropsychiatric conditions are treated. It also reflects our commitment to explore novel, shorter-acting formulations of psychedelic compounds which, we believe, will provide a more accessible treatment option with a lower burden on both patients and healthcare systems. We are optimistic about the potential of ELE-101 and are looking forward to evaluating the compound in future studies.”

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Beckley Psytech - www.beckleypsytech.com

Beckley Psytech is a private, clinical-stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by developing a pipeline of psychedelic compounds into licensed pharmaceutical medicines. The Company’s most advanced programmes are focused on the development of BPL-003, an intranasal synthetic formulation of 5-MeO-DMT, for treatment resistant depression (TRD) and ELE-101, an intravenous synthetic formulation of psilocin, the active metabolite of psilocybin, for major depressive disorder (MDD). Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, we combine world-leading psychedelic science with deep drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden these conditions have on individuals and society.