Veteran-focused psychedelics company Apex Labs Ltd. has secured Health Canada’s endorsement for its secondary US-based supplier of psilocybin Active Pharmaceutical Ingredient (API).
This approval bolsters Apex’s supply chain, paving the way for its upcoming clinical programs in North America.
The company is now transporting its synthetic psilocybin capsules across the border between Canada and the United States, having obtained the necessary permissions from Health Canada, the Drug Enforcement Administration (DEA) and US customs.
Co-founder and Chief Science Officer Orion Lekos said this development is a major advancement for the company’s drug development agenda. “Having a second GMP drug manufacturer in our portfolio provides us with dual sources of API, ensuring a steady supply of drug product,” he said.
The secondary manufacturer received Health Canada’s approval through an amendment to the Clinical Trial Application (CTA). Co-founder and CEO Tyler Powell underscored the significance of the US market, which accounts for half of the global pharmaceutical industry.
“This development, a result of years of collaboration and hard work by the Apex team, enables us to effectively carry out clinical trials and our early access program in both Canada and the US, with a secure drug supply in both markets,” Powell explained.
Powell also disclosed that Apex is currently implementing its US regulatory strategy by preparing to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in 2023, building on its regulatory submissions with Health Canada.
PATHFINDER-52 and SUMMIT-90 studies looking into psilocybin
Apex is conducting two comprehensive studies, PATHFINDER-52 and SUMMIT-90. These studies utilize microdose and macrodose psilocybin drug assets to address a range of disease severities across intended indications, meeting a significant unmet clinical need.
PATHFINDER-52, the largest approved take-home psilocybin clinical trial to date, is assessing the effects of multiple regular doses of Apex-52 microdose, an orally administered synthetic psilocybin drug product, in treating depression and anxiety in patients diagnosed with Post-Traumatic Stress Disorder (PTSD). The study aims to recruit 294 participants.
SUMMIT-90 is studying the effects of multiple doses of APEX-90 macrodose psilocybin, administered in a clinical setting with assisted psychotherapy, for the treatment of severe depression in PTSD-diagnosed patients. The study aims to recruit 160 Canadian patients, with the primary focus on researching severe depression within diagnosed PTSD. Additional areas of study include standalone PTSD symptoms, chronic pain and anxiety.
Apex is a pharmaceutical company that has clinically validated psilocybin treatments with a specific focus on Veteran patients, who represent a demographic with severe unmet needs and a robust mental healthcare infrastructure. Apex plans to extend its services to a wider global patient community in the future.