The trial enrolled subjects with moderate-to-severe depression who have not responded to a minimum of two previous treatments in the present depression episode. Credit: Pormezz/Shutterstock.
Beckley Psytech has completed subject enrolment for the core stage of the global Phase IIb clinical trial of patent-protected BPL-003 (mebufotenin benzoate), aimed at treating individuals with treatment-resistant depression (TRD).
The trial is aimed at assessing the safety and efficacy of the therapy’s single medium or high doses of 8mg or 12mg, respectively, against a sub-perceptual dose.
This intranasal formulation of mebufotenin benzoate is administered through a formerly approved nasal spray device.
The quadruple-masked, dose-finding trial enrolled 196 subjects across 38 sites in six nations. These individuals suffer from moderate-to-severe depression and have not responded to at least two previous treatments in the present depression episode, stated the company.
Subjects will be followed up for an eight-week period.
Using the Montgomery-Asberg Depression Rating Scale (MADRS), the centralised and blinded raters will assess the efficacy at different time points.
The eight-week, open-label extension stage will continue to enrol the subjects to assess the efficacy and safety of the therapy’s second high dose which was administered post the completion of the trial’s core stage.
Findings from the Phase IIb trial will be combined with data from the Phase IIa trial to support regulatory discussions and planning for Phase III in the second half of this year.
Topline outcomes from the Phase IIb trial’s core stage are anticipated in mid-2025.
Beckley Psytech CEO Cosmo Feilding Mellen said: “We are proud of the continued progress we are making with the clinical development of BPL-003 and we are excited to reach this critical milestone in our Phase IIb study.
“We are encouraged by the promising data from earlier clinical studies of BPL-003 – which have shown that a single dose of BPL-003 can produce rapid, significant, and lasting antidepressant effects – and we remain confident in BPL-003’s potential to transform the therapeutic landscape for people living with difficult-to-treat depression.”
In January 2024, a clinical-stage biopharmaceutical company atai Life Sciences made a strategic investment in Beckley Psytech.
In November 2022, Beckley Psytech [dosed the first subject](https://www.clinicaltrialsarena.com/news/beckley-psytech-trial-psychedelic-compound/) in the Phase I trial of ELE-101, a patent-protected, short-duration psychedelic candidate.