Aiming to transform mental health care with psilocybin.

APEX is a patient-driven pharmaceutical company 

Our mission is to develop, clinically evaluate and commercialize psilocybin drugs to tackle the most critical unmet need in depression and PTSD among Veterans and the general public. 

Our vision is to explore a new standard of care in mental health where physicians can prescribe APEX drugs globally.

Exploring a new standard of care 

Despite being the current standard of care treatment for depression and PTSD, studies antidepressants improve symptoms in around half of patients, highlighting the need to explore new options.

Market Opportunity

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  • 322 million

    People globally deal with depression

  • 280 million

    People globally suffer from PTSD

  • $19.5 Billion USD

    Forecasted size of the anxiety disorder and depression treatment markets by 2028

The APEX Strategy

Execute multiple clinical programs evaluating safety and efficacy of APEX drug assets for PTSD and depression in Canada, the US and Israel.

Commercial Strategy

Psilocybin has been studied in clinical trials to explore its potential applications in mental health. It remains a controlled substance, not approved for general medical use by Health Canada, and is only available under specific, controlled circumstances. APEX is currently evaluating two unique psilocybin drug assets seeking commercial approval optimized for all relevant disease states: 

  • Microdose drug candidate (APEX-52) optimized for take home dosing targeting moderate disease severity 
  • Macrodose drug candidate (APEX-90) positioned for in-clinic dosing with assisted psychotherapy targeting severe disease
  • Veteran patients have been dosed with both drug assets meeting all endpoints with no adverse events

Regulatory Strategy

Following Canadian phase 2b study completion with demonstrated outcomes, APEX will pursue commercial approval in the US, Canada, UK, EU, Israel and Australia.

Patient Focus

As a Veteran-founded organization, APEX is seeking indications for the general population and will prioritize Veteran patient communities that represent very high unmet need in clinical trial recruitment. APEX will leverage access to a network of thousands of Veteran patients and strong relationships with Veteran-focused practitioners to expedite recruitment to the most qualified patient candidates. 




Clinical Pathway

1

Q1 2023

Phase 2b “STEP-52” study completed. Working collaboratively with Health Canada APEX developed a proof-of-concept take home microdose study using APEX-52 drug product, the first of its kind. The trial completed meeting all endpoints with no adverse events.

2

Q1 2023

World’s largest take home microdose psilocybin clinical trial "PATHFINDER-52" authorized by Health Canada. 294 patient phase 2b study evaluating safety, efficacy and tolerability of APEX-52 in treating depression within diagnosed PTSD. Recruitment and trial launch Q3 2024.

3

Q2 2023

“SUMMIT-90” statistically powered 160 patient phase 2b clinical trial authorized by Health Canada April 14th 2023 using APEX-90 macrodose drug product in-clinic with assisted psychotherapy. Pre-screening complete and trial launch Q3 2024.

4

2025

With positive phase 2b data APEX will file for conditional approval (NOC/c) with Health Canada, moving to phase 3 studies seeking commercial authorization in US, Canada, UK, EU and Australia.

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