Apex Labs Ltd. a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, announces Health Canada
Approval of the company's secondary US-based supplier of Good Manufacturing Practices (GMP) psilocybin Active Pharmaceutical Ingredient (API) in addition to its existing primary Canadian-based supplier. APEX is actively shipping drug across the Canadian-US border with permit approvals from Health Canada, the Drug Enforcement Administration (DEA), and US customs.
"This is a large step forward for our drug development program," says Dr. Orion Lekos, APEX Co-Founder and Chief Science Officer. "Securing a second GMP drug manufacturer gives us two sources of API creating a sustainable supply of drug product to support our planned clinical programs in the US and Canada."
Health Canada authorization was received for the secondary manufacturer by way of a Clinical Trial Application (CTA) amendment.
"The United States represents half of the global pharmaceutical market. Following years of partnership development and effort by the APEX team, this facilitates our ability to successfully execute clinical trials and our Early Access Program in Canada and the US with drug supply established in both markets," says Tyler Powell, APEX Co-Founder and CEO. "As a result of our positive clinical progression with Health Canada, APEX is now executing our US regulatory strategy by filing an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) in 2023 leveraging our regulatory submissions with Health Canada."
About APEX Clinical Studies:
PATHFINDER-52 and SUMMIT-90 are statistically powered multi-centre randomized, double-blind, placebo-controlled phase 2b studies leveraging microdose and macrodose psilocybin drug assets.
APEX intends to optimize the two unique drug assets to target mild, moderate and severe disease across intended indications, addressing significant unmet clinical need.
PATHFINDER-52 evaluates multiple regular doses of APEX-52 microdose, take-home orally administered synthetic psilocybin drug product in treating depression and anxiety in patients with diagnosed Post-Traumatic Stress Disorder (PTSD), recruiting 294 subjects, the world's largest take home psilocybin clinical trial approved to date.
SUMMIT-90 evaluates multiple doses of APEX-90 macrodose psilocybin administered in-clinic with assisted psychotherapy for the treatment of severe depression in patients with diagnosed PTSD, recruiting 160 patients in Canada. SUMMIT-90's primary indication being studied is severe depression within diagnosed PTSD and secondary indications include standalone PTSD symptoms, chronic pain, and anxiety.
For more information please,Visit www.apexlabs.com
