First patient dosed in study of synthetic psychedelic for treatment-resistant depression
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Beckley Psytech announced dosing of the first patient in a phase 2b clinical trial of BPL-003, an intranasal synthetic formulation of the psychedelic compound 5-MeO-DMT for treatment-resistant depression.
According to a company release, the study — believed to be the largest controlled undertaking to investigate 5-MeO-DMT — will be conducted at 40 sites across Australia, Europe and the United States. The company received investigational new drug approval from the FDA in February for the short-acting, psychedelic compound.
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The randomized, quadruple-masked, dose-finding trial aims to evaluate effects of a medium or high dose of BPL-003, alongside psychological support, compared with placebo in 225 individuals with moderate to severe treatment-resistant depression.
Investigators will assess efficacy via the Montgomery-Asberg Depression Rating Scale at several time points during the trial, while psychological support will be given to all patients before, during and after dosing. An open label extension also is planned at select trial sites 8 weeks after initial dosing to examine the drug’s maintenance of effect following a second dose.
Initial results from the phase 2b trial are expected toward the end of 2024 and will be used alongside data from the company’s ongoing phase 2a study of BPL-003, the company stated.
“BPL-003 has so far generated strong safety and pharmacokinetic data and has been shown to reliably induce short-lasting and profound subjective effects, which correlate with positive therapeutic outcomes,” Beckley Psytech CEO Cosmo Feilding Mellen said in the release. “We are optimistic about entering the next stage of clinical development of BPL-003 with this study and we are looking forward to sharing more in the coming months.”