Beyond Magic Mushrooms: Positive Clinical Trial For Treatment-Resistant Depression & Alcoholism

Private clinical-stage psychedelics biotech Beckley Psytech announced it has successfully completed a Phase 1 clinical study on BPL-003, its patent-protected, synthetic intranasal formulation of 5-MeO-DMT under development for Treatment-Resistant Depression (TRD) and Alcohol Use Disorder (AUD.)

“We are pleased to report such positive initial findings from this Phase 1 study of BPL-003. The safety and tolerability profile, as well as the reliable induction of psychedelic experiences thus far, lay strong clinical foundations for BPL-003’s next stage of development and we are excited to move forward with our Phase 2 studies in the coming weeks,” said CSO Dr. Steve Wooding.

Cosmo Feilding Mellen, Beckley CEO further added that the team is “particularly impressed” with the fast onset and highly controllable delivery action of BPL-003, which they expect will improve accessibility for both physicians and patients. 

The double-blind, randomized, single-ascending dose study explored the safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support in 44 psychedelic-naïve participants, who were split into 6 cohorts and given either a single dose of 1mg to 12 mg of the drug or a placebo.

Initial results show a dose-proportional pharmacokinetic profile and good tolerability with no serious adverse events reported. BPL-003’s effects demonstrated onset within minutes and a duration of up to 90 minutes. 

The generated data so far gathered from the Phase 1 study will be used by the company to initiate its MHRA-approved Phase 2a studies evaluating the psychedelic compound in TRD and AUD in the last part of 2022.

Beckley Psytech’s other pipeline asset is ELE-101, an IV synthetic formulation of psilocin under development for Major Depressive Disorder (MDD) developed by recently-acquired Eleusis Therapeutics Ltd. The compound is a next-gen, short-duration psychedelic soon to be tested in Phase 1 clinical trials.

Photo by K. Mitch Hodge on Unsplash