Canadian Psychedelics Company Launches Take-Home Psilocybin Trial For Some 300 Participants

Apex Labs Ltd., an Iter Investment’s portfolio biopharma company developing psilocybin therapeutics, has been granted approval by Health Canada to begin its large take-home psilocybin clinical trial. 

The randomized, double-blind, placebo-controlled Phase 2b study will evaluate the efficacy, safety and tolerability of a microdose of APEX-52, the company’s proprietary oral synthetic psilocybin drug product, for the treatment of depression and anxiety in adults with diagnosed PTSD.

CEO Tyler Powell says the company’s focus is to execute “a rigorous clinical pathway,” and that positive results from this trial would allow Apex to move towards Phase 3 studies on the self-administered psilocybin product.

The study, which will be multi-centered, aims to recruit 294 adults with depression and anxiety with a PTSD diagnosis. Subjects not receiving placebo will be provided multiple doses of APEX-52, to be self-administered in an outpatient setting.

Trial sites will be located in Ontario and Atlantic Canada. Physicians will oversee patients throughout the whole trial, with patients receiving regular check-ins during the study period.

Recruitment will begin in the first half of 2023 and the trial will take place over the course of three months.

"After treating PTSD patients in my clinic for more than 20 years, we've seen the limitations of current treatments and the promise of psilocybin, but more research is required," said Dr. Mark Johnston, the trial’s PI and director of central nervous system research at Centricity Research. 

He added that the trial is significant in the sense that it will assess microdose psilocybin “at a scale never done before.”

Photo: Benzinga edit with photo by Pexels.