Beckley Psytech has commenced a Phase IIa clinical trial of synthetic 5-Methoxy-N, N-Dimethyltryptamine’s (5-MeO-DMT) intranasal formulation, BPL-003, for treatment resistant depression (TRD).

The company plans to enrol the first subject in the trial in January next year. 

The trial will be carried out at King’s College Hospital and Hammersmith Medicines Research.

It will evaluate the impact of one dose of BPL-003 plus psychological support in patients with moderate to severe symptoms of TRD. 

This trial will have such patients who are not receiving any antidepressants parallelly and be followed up for 12 weeks after the dosing.

Safety, pharmacokinetic and efficacy evaluations will be carried out at various time points throughout the trial. 

Additionally, the company plans to launch a second exploratory trial of the compound early next year. 

This study is expected to evaluate the impact of one dose of BPL-003 plus abstinence-oriented cognitive behavioural support in individuals with alcohol use disorder.

Beckley Psytech CEO Cosmo Feilding Mellen said: “Conditions like treatment resistant depression have a devastating effect on people around the world, but they are sadly underserved when it comes to treatment opportunities. 

“We are proud to be conducting rigorous scientific investigations into the therapeutic potential of novel, short-acting psychedelic compounds like BPL-003 to help people in urgent need and we are looking forward to dosing the first patient in the coming weeks.”

In November this year, the company concluded the Phase I trial of BPL-003 in 44 psychedelic-naïve subjects.

According to the trial findings, the treatment had a dose-proportional pharmacokinetic (PK) profile and favourable tolerability without any serious adverse events.