Beckley Psytech has released initial positive findings from its Phase IIa clinical study of BPL-003 for treating treatment-resistant depression (TRD).
The open-label trial assessed the safety, efficacy, and pharmacokinetics of a single 10mg intranasal dose of BPL-003, a synthetic benzoate salt formulation of 5-MeO-DMT, alongside psychological support.
It enrolled 12 subjects with moderate-to-severe TRD, not receiving other antidepressants.
Following the dosing, patients were monitored for 12 weeks with regular assessments.
Early analysis revealed a rapid antidepressant response in 55% of patients by the second day.
The findings highlight BPL-003's potential, with a significant number of patients showing remission from depression nearly a month after treatment.
The treatment was also found to be well-tolerated, with the majority of side effects being mild or moderate and no serious adverse events reported.
Beckley Psytech is optimistic about these results, which could pave the way for a scalable single-dose treatment model.
Based on these data, the company will extend the Phase IIa study to include patients on stable oral antidepressants, aiming to evaluate BPL-003 as an adjunctive therapy.
The upcoming multi-centre Phase IIb trial will validate the safety and efficacy of medium or high doses of BPL-003 versus a sub-perceptual dose in 225 TRD patients.
Results from this trial are anticipated in the second half of this year.
Beckley Psytech CEO Cosmo Feilding Mellen said: “We are delighted to see that a single dose of BPL-003 delivered a rapid and durable antidepressant response in patients with treatment-resistant depression.
“Our single-dose treatment model enables a short treatment duration, which positions BPL-003 as a potentially exciting and scalable treatment opportunity.
“Less than 15% of patients with treatment-resistant depression achieve long-term remission with the current standard of care, and we look forward to further validating the potential of BPL-003 as a treatment option with our ongoing Phase IIb study and subsequent clinical development programme.”
In April 2023, the company commenced a Phase IIa trial of its fast-acting psychedelic compound for treating alcohol use disorder.
