The first patient in Beckley Psytech’s trial investigating its patent-protected benzoate formulation of 5-MeO-DMT – BPL-003 – as a therapy for Treatment Resistant Depression (TRD) has now been dosed.
The multi-centre, open-label Phase IIa study will explore the effects of a single dose of BPL-003 in patients with Treatment Resistant Depression (TRD).
BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device.
The study is designed to evaluate the safety, efficacy and pharmacokinetics of a single dose of BPL-003 in combination with psychological support, in patients with moderate to severe TRD symptoms who are not taking concomitant antidepressants.
Patients will be followed for 12 weeks after initial dosing, with safety, pharmacokinetic and efficacy assessments conducted at multiple points throughout that period.
The study is currently recruiting at King’s College London and Hammersmith Medicines Research, and initial results are expected in 2023.
Dr Rob Conley, Chief Scientific Officer at Beckley Psytech, said: “Dosing the first patient in this study is hugely exciting, and we are looking forward to exploring the potential therapeutic effects of BPL-003 for patients living with Treatment Resistant Depression.
“Around one third of all people living with depression are resistant to currently available antidepressants and there is an urgent need for more effective treatments.
“We are proud to be leading the way in developing alternative therapies that are safe, effective and practical and we hope to have more to share soon.”
So far, Phase I data has shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-proportional pharmacokinetic profile. Medium and high dosages were found to reliably induce profound psychedelic experiences (a correlate of positive clinical outcomes) with a rapid onset and timely offset (60 to 90 minutes) of psychedelic treatment effects.
Topline results will be used alongside data from Beckley Psytech’s global multi-site Phase IIb study of BPL-003 in patients with TRD to inform the future clinical development of BPL-003.
Beckley Psytech received the Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase IIb clinical trial of a short-acting psychedelic in February 2023.
The study, which is taking place at 40 investigator sites across 7 different countries, will evaluate the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in patients with moderate to severe TRD who are not taking concomitant antidepressants. Initial results from that study are expected in 2024.
