Phase 2a study initiated to examine synthetic DMT for treatment-resistant depression

A biotech company based in the U.K. announced that it has initiated a phase 2a study for BPL-003 for treatment-resistant depression.

According to a release issued by Beckley Psytech, the study will occur at King’s College Hospital and Hammersmith Medicines Research in the U.K. and seeks to explore the effects of a single dose of BPL-003, a proprietary intranasal formulation of synthetic 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT), in combination with psychological support, for those with moderate to severe TRD symptoms who are not taking concomitant antidepressants.

“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,” Beckley Psytech CEO Cosmo Mellen said in the release. “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.”

Per the release, the first patient is expected to be enrolled in January. After initial dosing, participants will be followed for 12 weeks with safety, pharmacokinetic and efficacy assessments conducted at multiple points throughout the study period.

“Having been a part of Beckley Psytech's successful phase 1 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,” James Rucker, PhD, principal investigator of the trial, said in the release.

The company additionally revealed in the release that a second exploratory study, investigating the effects of a single-dose of BPL-003 alongside abstinence-oriented cognitive behavioral support in people suffering with alcohol use disorder, is expected to be initiated in early 2023.