Beckley Psytech has announced positive topline results from its phase 2a study of ELE-101, a synthetic intravenous (IV) formulation of psilocin benzoate, for patients with Major Depressive Disorder (MDD).
The study demonstrated that a single dose of ELE-101 can deliver rapid, robust, and lasting antidepressant effects for up to three months. The open-label study evaluated the safety, tolerability, and efficacy of a single IV dose of ELE-101 in six patients with MDD. A single 10-minute infusion of ELE-101 resulted in a significant antidepressant response, with a mean reduction of more than 20 points in MADRS scores observed at all time points through to three months.
Four out of six subjects achieved remission the day after dosing, and this effect was sustained in the majority of patients at day 90. Dr Rob Conley, Beckley Psytech’s Chief Scientific and Medical Officer, stated, “Initial findings indicate that our innovative intravenous formulation has the potential to provide an effective and rapid-acting treatment option for those suffering from depression.”
ELE-101 showed a good safety and tolerability profile, with patients ready for discharge approximately two hours after administration. Developed in-house by Beckley Psytech, ELE-101 is designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm. It aims to produce rapid onset and reduced inter-subject variability compared to oral formulations of psilocybin.
Following the successful Phase I trial of ELE-101, which showed a dose-proportional pharmacokinetic profile and reliable induction of acute effects, Beckley Psytech plans to further develop ELE-101 in larger studies. Dr Conley added, “Whilst this was a small, proof-of-concept study, we are greatly encouraged by the results and look forward to planning larger studies in the coming months.”
Beckley Psytech continues to advance its portfolio of rapid-acting, short-duration treatment options for mental health conditions.
