Aiming to transform mental health care with psilocybin.

APEX is a patient-driven pharmaceutical company 

Our mission: Develop clinically evaluate and commercialize psilocybin drugs to address the most critical unmet need in depression and PTSD.

Our vision: Explore a new standard of care in mental health where physicians can access and prescribe APEX drugs globally.

Exploring a new standard of care 

The National Institute of Health reports the current rate of effectiveness with antidepressant standard of care therapy is between 40-60%, with 50% of people treated reporting unwanted side effects.

It’s time we explore new options. 

Market Opportunity

  • 1
  • 2
  • 3

  • 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 clinical value 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: 

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

Regulatory Strategy

Following our Canadian phase 2b study completion in Canada APEX will pursue phase 3 trials and commercial approval. In parallel, APEX is evaluating and pursuing clinical development and commercial approval for the US, Israeli, EU and Australian markets. 

Patient Focus

Trauma and PTSD are growing global problems affecting diverse populations with Veterans facing PTSD at higher rates, published by Veteran Affairs organizations in multiple countries.

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.

Learn about our approach
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