Beckley Psytech has dosed the first participant in its Phase 1 single-ascending dose (SAD) study of ELE-101 – a novel intravenous formulation of psilocin – 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.
Beckley Psytech, is carrying out the 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.
CEO of Beckley Psytech, Cosmo Feilding Mellen, 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.”
Blinded data will be used to help design the Phase 2a 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 company has stated its 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.
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 2a studies in depression and Alcohol Use Disorder (AUD).
