Drug Development

1

GMP API

APEX leverages multiple lab partners across Canada and the US ensuring supply chain stability to manufacture its Active Pharmaceutical Ingredients (API) under Good Manufacturing Practices (GMP)assisting in cross-border transportation. APEX has completed significant research and development to formulate a unique capsule for use in clinical trials.

2

Research & Development

Dr. Orion Lekos oversees Research and Development (R&D) alongside Dr. Bal Kang to lead exploration of Intellectual Property (IP) formulations for APEX’s synthetic psilocybin drug products used in upcoming clinical trials and medical access.

Clinical Pipeline

There is not one size-fits all when it comes to psilocybin therapies. Some patients may be best suited to in-clinic macrodose psilocybin with assisted psychotherapy, while others are best suited for take home microdose psilocybin. 

APEX-52 microdose take home drug

Potential to be optimized for moderate disease severity.

    1. STEP-52 Risk mitigation study completed: First patient with PTSD dosed with APEX-52 in take home microdose phase 2b stability study in January 2023. The trial completed March 29th 2023 and met all endpoints with no adverse events.
    2. World largest take home psilocybin clinical trial (PATHFINDER-52) authorized by Health Canada January 2023. Phase 2b double-blind, placebo controlled clinical study to evaluate safety, efficacy and tolerability, recruiting 294 patients and beginning Q3 2024.

APEX-90 macrodose drug for in-clinic dosing with assisted psychotherapy

Potential to be optimized for severe disease. 

  • SUMMIT-90 statistically powered 160 patient macrodose phase 2b clinical trial using APEX-90 drug product authorized by Health Canada April 14th 2023. Pre-screening completed and trial launch Q3 2024.

Patient Recruitment

The best way to optimize clinical trial costs, speed and outcomes is to expedite recruitment to the most qualified patient candidates. 

A Veteran-First Approach

As a Veteran-founded organization and in alignment with our mission to address the highest areas of unmet need, APEX’s research team will be initially focused on Veteran communities in trial recruitment who have the most severe mental health disease burden. APEX has access to a network of thousands of Canadian Armed Forces and RCMP Veteran patients and strong relationships with Veteran-focused practitioners sufficient to support swift clinical trial enrolment.

APEX aims to secure clinical indications for the general population, including Veterans.