Beckley Psytech has confirmed it has dosed the first patient in its international Phase 2b study of BPL-003 – a novel synthetic intranasal formulation of 5-MeO-DMT – for Treatment Resistant Depression (TRD).
The trial is the largest ever efficacy study of 5-MeO-DMT (also known as Mebufotenin) and is taking place at 40 sites across six countries, with initial study results expected in 2024.
The multi-centre, quadruply-masked Phase 2b study aims to assess the efficacy and safety of different doses 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 taking place at 40 sites across Australia, Germany, Poland, Spain, the United Kingdom and the United States.
It follows Beckley Psytech’s receipt of the U.S. Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase 2b study of a short-acting psychedelic compound in February this year.
Beckley Psytech’s CEO, Cosmo Feilding Mellen, said: “We’re proud to be leading the way in exploring how short-acting psychedelics like 5-MeO-DMT could help address the huge unmet need faced by millions of people living with Treatment Resistant Depression around the world.
“BPL-003 has so far generated strong safety and pharmacokinetic data, and has been shown to reliably induce short-lasting and profound subjective effects, which correlate with positive therapeutic outcomes.
“We are optimistic about entering the next stage of clinical development of BPL-003 with this study and we are looking forward to sharing more in the coming months.”
The trial
The randomised, dose-finding trial will evaluate the effects of a medium or high dose of BPL-003, alongside psychological support, against an active placebo in 225 patients with moderate to severe TRD.
The study will be quadruply masked, with the patient, investigator, therapist and outcomes assessor all masked to the dose allocation of the subject in order to reduce expectancy bias. Efficacy will be assessed by masked raters using the Montgomery-Asberg Depression Rating Scale (MADRS) at several time points during the trial and psychological support will be given to all patients before, during and after dosing.
The team also plan to run an open-label extension at some of the trial sites eight weeks after initial dosing to explore BPL-003’s maintenance of effect following a second dose.
The doses for this Phase 2b study were selected after Beckley Psytech’s preclinical and Phase I studies showed BPL-003 to be well-tolerated with a predictable dose-linear pharmacokinetic profile. Medium and high dosages were found to reliably induce profound psychedelic experiences with a rapid onset of psychedelic treatment effects within minutes and the resolution of all perceptual effects within 60 to 90 minutes.
Dr Rob Conley, Beckley Psytech’s Chief Scientific Officer, added: “Getting to the first patient being dosed in this study has truly been a global collaboration. We’ve worked with international experts on the study design, trained around 170 therapists from around the world, and are collaborating with 40 highly qualified clinical trial sites in 6 different countries.
“I would like to take this opportunity to thank everyone who has been involved with our clinical programme so far, as well as the current and future patients who are willing to participate in our trials. We are ever grateful for your time and trust.”
Beckley Psytech has partnered with leading full-service global contract research organisation (CRO) Worldwide Clinical Trials to run the study, while Fluence has provided training for the standardised psychological support that will be offered to patients in the trial.
Initial results will be used alongside data from Beckley Psytech’s ongoing Phase 2a study of BPL-003 for TRD to inform the future clinical development of the compound.
