APEX’s clinical development program is focused on Veterans and First Nations – groups that are disproportionately affected by mental disorders. The Company’s lead clinical candidate is a low dose synthetic psilocin product for the treatment of Post Traumatic Stress Disorder (PTSD).
APEX’s strategy is to develop drug products including Active Pharmaceutical Ingredients (API) produced by chemical synthesis, and also drug products with botanically-sourced API, differentiating APEX from the pack by diversifying APEX’s options for development and commercialization of drug products.
APEX is currently engaged with Health Canada and one of the world’s leading patient advisory groups to launch clinical trials for Veterans, First Responders and First Nations. Having a study approved by Health Canada will simplify having a study approved by the FDA*.
APEX has a Joint Venture Agreement with Innovate to cultivate, extract, formulate, import and export controlled substances for the benefit of Apex’s clinical trials. Innovate’s DL site is built to Compliance with Level 6 of the Security Directive**, allowing ample storage of controlled substances to secure North American supply.
APEX will launch multiple clinical trials with Veterans, First Responders and First Nations in Canada and the US with the team that assisted the PTSD Phase 2 and Phase 3 MDMA*** clinical trials for MAPS.
* Food and Drug Administration
** Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis