Apex Labs Ltd. (APEX or the Company), a pharmaceutical company optimizing the standard of mental health care with psilocybin, is pleased to its approval by Health Canada to begin APEX-002-A01-03.
The world's largest take home psilocybin clinical trial approved to date. This randomized, double-blind, placebo-controlled phase 2b study will evaluate the efficacy, safety and tolerability of APEX-52 microdose, orally administered synthetic psilocybin drug product in treating depression and anxiety among adults diagnosed with Post-Traumatic Stress Disorder (PTSD). The approval comes by way of a No Objection Letter (NOL) from Health Canada received on January 5th 2023.
"We are incredibly proud of the team for making APEX the first-mover in take home psilocybin treatment" Tyler Powell, APEX Chief Executive Officer comments. "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 3 commercialization studies."
APEX-52 is a microdose, orally administered psilocybin drug product dosed regularly per the study protocol, manufactured under Good Manufacturing Practices (GMP), which is currently formulated, packaged, and labeled for self-administered patient dosing.
APEX-002-A01-03 is a multi-centre, randomized, double-blinded, placebo-controlled trial aiming to recruit 294 adult subjects with depression and anxiety in diagnosed PTSD.
Subjects not receiving placebo will be provided multiple doses of APEX-52 which will be self-administered in an outpatient setting. Efficacy will be evaluated against globally recognized scales 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," says 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."
Physician oversight will be present for the duration of the trial, with patients receiving regular check-ins during the study period.
Trial sites will be located in Ontario and Atlantic Canada. Recruitment will begin in the first half of 2023 and the trial will take place over the course of three months.
"As a Canadian company we are excited to conduct this trial in our own backyard," says 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."
APEX is a portfolio company of Iter Investments, with Managing Principal Dustin Robinson Esq. adding, "We have supported APEX since the early stages and are thrilled to see their hard work and our belief in the team pay off with this industry-changing approval."
