Beckley Psytech Doses First Patients With Psilocin In Trial For Treatment Of Major Depression Disorder

The UK-based psychedelics medicine company Beckley Psytech announced Thursday that it has dosed its first patients in a Phase IIa study (NCT05434156) of ELE-101, a patent-protected synthetic formulation of psilocin benzoate to treat major depressive disorder (MDD). Psilocin is the active metabolite of psilocybin and ELE-101 has been specifically designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions.

"Dosing the first patients in our Phase II study marks an important milestone in our clinical development programme of ELE-101 as we investigate its potential as an effective and rapid-acting intervention for depression," Dr. Rob Conley, Beckley Psytech's chief scientific and medical officer stated. "This study builds on the foundational work from our Phase I study in healthy volunteers and we plan to share more detailed findings from that trial at a later date. We are proud to be leading the way in exploring how short-duration psychedelics like ELE-101 could address the huge unmet need faced by the millions of people living with depression around the world and the healthcare systems who support them."

The open-label study is evaluating the safety, tolerability, subjective effects and efficacy of a single intravenous dose of ELE-101 in 6-12 patients diagnosed with MDD. Patients will be assessed at various time points in the study for up to three months following the dose and results of the study are expected in the second half of the year.

The dose was selected using preliminary data from the company's double-blind, placebo-controlled, randomised Phase I study of ELE-101, which sought to identify a dose that was well-tolerated and induced high-intensity, short-duration psychedelic experiences in healthy participants. The data indicated that ELE-101 was well-tolerated with no serious or severe adverse events reported. ELE-101 demonstrated a reliable induction of high-intensity, short-duration psychedelic experiences, which suggests the potential for a short time in the clinic of approximately 2 hours.

News of the study comes several weeks after the company shared an update on new research studying the neurophysiological effects of BPL-003, the company’s novel synthetic intranasal formulation of 5-MeO-DMT (also known as mebufotenin), on the human brain.

See Also: Atai Invests $50M In Beckley Psytech For Short-Duration Psychedelics Development

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