Apex Labs received approval from Health Canada to begin the “world’s largest take home psilocybin clinical trial.” The Phase 2b trial will test the company’s psilocybin-based treatment for depression and anxiety among adults diagnosed with post-traumatic stress disorder (PTSD).
The drug candidate at the center of the trial is APEX-52, which is an orally administered synthetic psilocybin drug product that will be delivered as a ‘microdose’, and therefore does not initiate a psychedelic experience for recipients.
According to the company, the drug candidate is dosed regularly per study protocol and is produced through good manufacturing practice (GMP). The product is formulated, packaged, and labeled for self-administered patient dosing.
Health Canada - 'no objection'
The trial was given the go-ahead after Apex received a ‘no objection letter’ from Health Canada at the beginning of January 2023.
The trial is aiming to include 294 adult subjects, and the trial itself is a multi-center, randomized, double-blinded, placebo controlled trial. The participants receiving APEX-52 will self-administer the treatment in an outpatient setting.
Mark Johnston, APEX-002-A01-03 principal investigator and director of Central Nervous System Research at Centricity Research, said, “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.”
Recruitment for the trial will begin in the first half of 2023, and the trial will take place over the course of three months. The trial sites will be located in Ontario and Atlantic Canada.
There have been previous attempts to measure the potential for microdosing psilocybin, with some finding benefits, and others suggesting that it worked only similarly to placebo. However, as noted by Johnston, Apex’s trial is differentiated based on the scale at which the new trial is taking place.
Apex is a portfolio company of Iter Investments, which has made investment across ‘multiple sectors of the psychedelic value chain’. In July 2022, the venture capital firm raised over $20m (€18.5m) to support and build out companies invested in various psychedelic compounds.
Across the pharma industry, there is a broadening interest of the potential for such types of therapy to achieve breakthrough success, particularly when it comes to treating mental health conditions.