IV Psilocin Benzoate for Major Depressive Disorder: New Phase 2a Results

charnsitr/AdobeStock

Beckley Psytech announced positive topline results from its open-label phase 2a study of intravenous (IV) psilocin benzoate (ELE-101) in patients with major depressive disorder (MDD), which showed that the treatment delivers rapid, lasting antidepressant effects for up to 3 months following a single dose.¹

This patent-protected, synthetic formulation of psilocin benzoate was specifically designed to provide consistent, controllable drug delivery in patients with neuropsychiatric conditions. It provides IV delivery of the active metabolite of psilocybin and has the potential to produce a more rapid onset, significantly shorter treatment duration, as well as reduced inter-subject variability compared with oral formulations of psilocybin.

The phase 2a study evaluated the safety, tolerability, subjective effects, and efficacy of a single IV dose of psilocin benzoate in 6 participants diagnosed with MDD. Initial data show that a single dose, delivered via a 10-minute infusion, induced a rapid and clinically significant antidepressant response in most participants. In the 4 participants evaluable at 3 months, effects were sustained. There was a 25 point mean reduction in MADRS scores seen the day after dosing, and 4 of 6 participants had MADRS scores of 10 or less immediately the day after dosing, considered as remission. A greater than 20-point reduction in MADRS scores was also observed at all time points through to 3 months after dosing, with all 4 subjects evaluable at day 90 after dosing meeting the remission criteria.

Psilocin benzoate was well-tolerated with mostly mild, transient adverse events. No serious or severe adverse events were reported. Acute effects resolved and patients were deemed ready to be discharged by investigators within a mean time of approximately 2 hours. Investigators selected the dose for this study using preliminary pharmacokinetic and pharmacodynamic data from Beckley Psytech’s double-blind, placebo-controlled, randomized phase 1 study of ELE-101, which completed dosing early in 2024.

“These positive 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, with a good safety and tolerability profile and lasting effects from a single dose,” said Rob Conley, Beckley Psytech’s chief scientific and medical officer. “Whilst this was a small, proof-of-concept study, we are greatly encouraged by the results and we are looking forward to planning larger studies of ELE-101 in the coming months.”

Earlier this year, Beckley Psytech’s shared data on another of its rapid-acting, short-duration treatment options: BPL-003. A synthetic benzoate formulation of 5-MeO-DMT, BPL-003 is currently in phase 2 studies for the treatment of depression and alcohol use disorder. Initial results from a phase 2a study of BPL-003 for treatment-resistant depression in March 2024 showed that a single dose of BPL-003 rapidly induced an antidepressant response in 55% of patients the day after dosing (day 2). Approximately 55% of patients experienced remission of depressive symptoms at day 29 and 45% of patients experienced remission of depressive symptoms at day 85, demonstrating the longevity of effect. BPL-003 also takes effect quickly in the clinic, wi.th patients assessed as ready for discharge by the investigators in 2 hours or less, on average.²

References

1. Beckley Psytech announces positive topline results from phase IIa study of ELE-101 (IV psilocin benzoate) for major depressive disorder. News release. December 17, 2024. Accessed December 18, 2024. https://www.beckleypsytech.com/posts/beckley-psytech-announces-positive-topline-results-from-phase-iia-study-of-ele-101-for-major-depressive-disorder

2. Kuntz L. First participant dosed in study of BPL-003 neurophysiological effects. Psychiatric Times. June 3, 2024. https://www.psychiatrictimes.com/view/first-participant-dosed-in-study-of-bpl-003-neurophysiological-effects