Optimizing the standard of mental health care for Veterans.
APEX is a patient-driven pharmaceutical company bringing data supported, clinically evaluated psilocybin-derived treatments to market for depression in Veterans with PTSD.
We built APEX for the patients we serve and are driven by an experienced and passionate leadership team from the Veteran community, healthcare, drug policy and emerging sectors who want to make a difference and disrupt the $380+ billion-dollar global mental health market.
Severe Unmet Need
An estimated 351 million people globally are living with PTSD and incidence rates among Veterans can be twice that of the general public. The symptoms are severe, making it hard to transition to civilian life and participate in the labour market and taxing financial and healthcare systems. Few Veterans are effectively treated.
An Inadequate Standard of Care
Most Veterans with PTSD are treated with traditional antidepressants (SSRIs), but they have brutal side effects, take a long time to find the right dose, and half of patients end treatment early. It has been estimated that only 20-30% of Veterans with PTSD are effectively treated with traditional antidepressants.
Future with Psilocybin
Psilocybin has been studied extensively, demonstrated safety, and shown promise for the treatment of a variety of conditions like depression and anxiety. Unlike traditional antidepressants, psilocybin has not been linked with physical dependence and is associated with less severe side effects.
This is why regulatory bodies are accelerating pathways to medical access. Psilocybin recently received breakthrough designation from the US FDA for its potential treatment of depression, and Health Canada broadened the Special Access Program (SAP) in January 2022 to include psilocybin.
The APEX Approach
Develop pharmaceutical products through a phased clinical program while evaluating safety and efficacy in a real-world setting. We have multiple drug candidates in the pipeline, including a low-dose synthetic psilocybin-derived treatment currently seeking Health Canada approval.
Work directly with our network of Veterans, a patient base with insurer coverage, and practitioners to develop effective, early medical access channels to get patients the care they need now.
Bring data supported, clinically evaluated psilocybin-derived drugs to market for depression in Veterans with PTSD.
Fast-track our clinical program and lay the infrastructure to develop innovative pharmaceuticals targeted at a broad range of mental health conditions.
This is only the beginning. We are laying the infrastructure to leverage an array of New Chemical Entities (NCEs) to develop innovative pharmaceuticals targeted at a broad range of mental health conditions.
Clinical Trial Pipeline
APEX-002-A01-01 approved phase 2a Clinical Trial Application (“CTA”) with Health Canada by way of No Objection Letter (“NOL”) for a randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability and efficacy of psilocybin in Veterans with PTSD using APEX-002 GMP drug product.
APEX-002-A01-02 approved phase 2b CTA with Health Canada by way of NOL for the first North American take home, low-dose, multi-dose psilocybin clinical trial aimed at supporting depression in Veterans with PTSD using APEX-52 GMP drug product.
APEX-002-A01-03 CTA to be filed with Health Canada and potentially additional regulatory bodies for a commercialization study bringing APEX-52 GMP drug product to market.