Phase IIa study begins in treatment resistant depression

Nasal spray

Beckley Psytech has initiated a Phase IIa study investigating BPL-003, a proprietary intranasal formulation of synthetic 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT), for treatment resistant depression (TRD). 

Depression affects around 280 million people around the world, but 30% of those living with the condition are resistant to available antidepressant medications, meaning there is an urgent need for more effective treatments. 

The Phase IIa study (NCT05660642) will explore the effects of a single dose of BPL-003, in combination with psychological support, in TRD patients with moderate to severe 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 first patient is expected to be enrolled in January 2023.  

Dr James Rucker, Consultant Psychiatrist and Senior Clinical Lecturer, leads the Psychoactive Trials Group at King’s College London and is the Principal Investigator of the trial. He said: “Having been a part of Beckley Psytech’s successful Phase I studies of 5-MeO-DMT, we are looking forward to exploring the safety, tolerability and efficacy of intranasal BPL-003 in further clinical trials with those suffering with treatment resistant depression.  

“These studies will inform the development pathway for BPL-003 in this common and devastating mood disorder.” 

A second exploratory study, investigating the effects of a single-dose of BPL-003 alongside abstinence-oriented cognitive behavioural support in people suffering with alcohol use disorder, is also expected to be initiated in early 2023.

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