Clinical Trials

Beckley Psytech Ltd, a clinical-stage biopharmaceutical company that specialises in the production of accessible medicines for mental health conditions, has announced positive results for the phase 2a study into BPL-003 in patients with moderate-to-severe alcohol use disorder (AUD).

The study, labelled NCT05674929, was conducted at King’s College London and Clerkenwell Health, both in the UK. The aim was to evaluate the tolerability, safety, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003, a synthetic intranasal benzoate, on a total of 12 patients who were diagnosed with moderate-to-severe AUD.

Dr Rob Conley, Beckley Psytech’s chief scientific and medical officer, said: “These findings contribute to a growing evidence base demonstrating the potential efficacy of psychedelic-based treatments to address the needs of those living with AUD. We have shown that BPL-003 is safe and tolerable, and that a single dose can deliver a rapid and durable effect within a short time in the clinic. We now plan to use this data to inform the development of further clinical studies that will investigate BPL-003 as an effective, rapid-acting and accessible treatment option for substance use disorders. I would like to take this opportunity to thank the participants and research teams who have made this study possible.”

Results show that the mean number of alcohol units being consumed per day had decreased from 9.3 (taken 12 weeks before the dosing) to 2.2 (taken 12 weeks postdosing). The study also examined heavy drinking days (HDD), defined as days where an individual consumed over 7 units for a female and over 9 units for a male. For comparison, the UK’s most popular beer in 2023 contains 2.6 units of alcohol per pint. On average, 56% of patients in the study had a drop in HDD from the pre-dose period to 13%. Contrastingly, the average of days where patients abstained from alcohol increased from 33% to 81%.