22 February 2023 - - UK-based clinical-stage biotechnology company Beckley Psytech Ltd has received Investigational New Drug approval from the US Food and Drug Administration for a global multi-site Phase IIb study exploring the safety, efficacy and tolerability of two distinct doses of its lead compound, BPL–003, in patients with Treatment Resistant Depression.

BPL-003 is Beckley Psytech's novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.

This IND marks the first time the FDA has ever given IND approval for a Phase IIb study of a short-acting psychedelic treatment or a 5-MeO-DMT treatment.

The study will be conducted with the help of 40 investigator sites in 7 different countries and is due to be initiated in H1 2023.

Phase I data has already shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile.

Medium and high dosages were found to reliably induce profound psychedelic experiences, which might be correlated with positive clinical outcomes, with a rapid onset of psychedelic treatment effects within minutes.

All perceptual effects were resolved within 60-90 minutes.

Beckley Psytech's Phase IIb randomised, dose-finding study 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.

The study will be quadruply masked, with the patient, investigator, attendant and outcomes assessor all blinded to the dose allocation of the subject to reduce expectancy bias.

Efficacy will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) at several time points during the trial.

The Phase IIb study, which is fully funded from Beckley Psytech's existing cash reserves, will complement the company's ongoing Phase IIa study of BPL-003 for TRD and initial results are expected in 2024.

It is estimated that nearly 300 m people around the globe have depression but, for many of those living with the condition, even the best current medicines either do not work or have side effects that leave them unable to experience life to the fullest. 

33% of patients are resistant to available treatments, such as selective serotonin reuptake inhibitors (SSRIs), and 60% of patients discontinue or switch SSRIs within 12 weeks due to side effects.

Beckley Psytech Ltd is a private, clinical-stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by transforming psychedelics into safe, effective and licensed medicines.

The company's most advanced programmes are focused on the development of BPL-003, an intranasal synthetic formulation of 5-MeO-DMT, for people with Treatment Resistant Depression and Alcohol Use Disorder, and ELE-101, an intravenous synthetic formulation of psilocin, for people with Major Depressive Disorder.

Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech combines psychedelic science with extensive drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden neuropsychiatric conditions have on individuals, healthcare systems and society.