Clinical-stage biotechnology firm Beckley Psytech has dosed the first subject in its Phase I trial of the new short-acting psychedelic compound ELE-101.
The randomised, placebo-controlled, double-blind study has been designed to evaluate the tolerability, pharmacodynamic (PD), safety, pharmacokinetic (PK) profile, and subjective drug intensity (SDI) of ELE-101 single ascending intravenous doses in up to 60 healthy adults.
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ELE-101 is an intravenous synthetic formulation of psilocin, the active psilocybin metabolite, to treat major depressive disorder (MDD).
It can provide a more consistent and controllable response in patients, with a quick onset, significantly less treatment duration and variability compared to oral formulations of psilocybin.
The company added ELE-101 to its portfolio after purchasing Eleusis Therapeutics last month.
Beckley Psytech CEO 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.
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By GlobalData“It also reflects our commitment to exploring 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 look forward to evaluating the compound in future studies.”
The company expects to receive the complete results of the study in the first half of next year.
It intends to use the blinded data to help design a Phase IIa study, which is planned to commence during the same period.
Beckley Psytech team expects that ELE-101 has the potential to address a few observed limitations of oral psilocybin, including long duration of action and variability in responses of patients.
