Optimizing the standard of mental health care with clinically proven psilocybin treatments.

APEX is a patient-driven pharmaceutical company. 

Our mission is to develop and commercialize clinically evaluated psilocybin-derived treatments to tackle the most critical unmet need in depression, anxiety, and PTSD among Veterans and the general public. 

Our vision is to work with regulators and advocacy groups to expedite our clinical programs and data capture to facilitate broader global access.

Addressing a sub-optimal standard of care 

“The drug effect of antidepressants is not clinically significant. If they are to be used at all, it should be as a last resort.”

– Dr. Irving Kirsch,  Associate Director, Placebo Studies at the Harvard Medical School

Despite being the current standard of care treatment for depression, anxiety and PTSD, studies estimate antidepressants only improved symptoms in around 20% of people, marking substantial unmet need. 

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

Develop and commercialize pharmaceutical assets that address significant unmet need across many established patient segments through phased clinical trial pipelines and a robust early access program (EAP).

Commercial strategy

APEX is currently evaluating two unique drug assets seeking Health Canada Approval that will be optimized for all relevant disease states: 

  • Microdose drug candidate (APEX-52) optimized for take-home dosing targeting mild to moderate disease severity 
  • Macro-dose drug candidate (APEX-90) positioned for in-clinic dosing with assisted psychotherapy targeting more severe disease

Regulatory Strategy

Following Canadian phase 2b study completion with demonstrated outcomes, APEX will pursue a regulatory pathway towards commercial approval in the US, Europe and Australia.

Patient Focus

As a Veteran-founded organization, APEX will prioritize Veteran patient communities that represent very high unmet need in clinical trial recruitment and the EAP. 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

First patient with PTSD effectively dosed in phase 2b “STEP-52” study. Working collaboratively with Health Canada APEX developed a proof of concept take-home microdose risk mitigation study using APEX-52 drug product, the first of its kind.

2

Q1 2023

World’s largest take-home microdose psilocybin clinical trial "PATHFINDER-52" approved by Health Canada. 294-patient phase 2b study designed as a randomized double-blind placebo-controlled trial evaluating safety, efficacy and tolerability of APEX-52 in treating depression and anxiety within diagnosed PTSD. Recruitment and trial launch Q2 2023.

3

Q1 2023

“SUMMIT-90” CTA submitted March 20th. Statistically powered 160 patient phase 2b clinical trial to use APEX-90 macro-dose drug product in-clinic with assisted psychotherapy.

4

Pivotal Phase 3

After completing phase 2b clinical studies in Canada, APEX will use learnings from Health Canada to optimally execute phase 3 program aimed in multiple regulatory jurisdictions.

Learn about our approach
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