World's largest psychedelic drug trial approved by Health Canada

Apex Labs, a leader in psychedelic medicine, gains a No Objection Letter from Health Canada, meaning they can start recruiting for their latest trial. 

Apex Labs (Vancouver, Canada) specialises in bringing psilocybin-derived treatments to market for patients with depression and anxiety in PTSD. They will be starting a randomised, double-blind, placebo-controlled Phase IIb study – APEX-002-A01-03 – to test the safety of APEX-52 for the treatment of anxiety and depression in adults with PTSD. 

APEX-52 is a microdose, orally administered synthetic psilocybin drug product. Administered as a microdose means that the patients wouldn’t experience psychedelic events. Apex labs is hoping to recruit 294 patients from across Canada. Trials have been conducted with PAE-52 before, but not to this proposed scale.

"We are incredibly proud of the team for making APEX the first-mover in take home psilocybin treatment" Tyler Powell, APEX Chief Executive Officer commented. "Our focus is to execute a rigorous clinical pathway and positive results from APEX-002-A01-03 will allow APEX to move swiftly into Phase III commercialisation studies."

The patients will self-administer the dose, with the drug carefully manufactured according to guidelines and under GMP, making it safe and easy for home use, with physician oversight and regular check ins. 

The tolerability and efficacy of the drug will be measured against the global standards for anxiety, depression, PTSD and suicidality, compared to baseline. 

"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," stated Dr Mark Johnston, APEX-002-A01-03 Principal Investigator and Director of Central Nervous System Research at Centricity Research. "This trial is significant as we are studying microdose psilocybin at a scale never done before. Microdoses are not associated with an intense psychedelic effect, allowing them to be taken at home and offering an easy to access, yet potentially equally effective pathway for psilocybin. Centricity has the facilities and operational expertise to begin a trial of this complexity swiftly."

Apex will be recruiting for the trial in the first half of 2023, with the trial then taking place over a three month period. 

"As a Canadian company we are excited to conduct this trial in our own backyard," commented Arron Victory, APEX Chief Strategy Officer and Canadian Armed Forces Veteran. "We have been incredibly pleased with Health Canada's efficient, thoughtful feedback and support across APEX submissions, exemptions, and approvals."