Transforming mental health care with psilocybin treatments.
APEX is a patient-driven pharmaceutical company and a licenced dealer of psiloycbin.
Our mission is to develop and commercialize clinically evaluated psilocybin treatments to tackle the most critical unmet need in depression and PTSD among Veterans and the general public.
Our visionis to unseat antidepressants as the standard of care in mental health allowing physicians to prescribe APEX drugs globally.
Addressing a sub-optimal standard of care
Despite being the current standard of care treatment for depression and PTSD, studies estimate antidepressants improve symptoms in around half of patients, a coin toss at best.
People globally deal with depression
People globallysuffer 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 alongside an Early Access Program (EAP) currently dosing Veteran patients creating real world data and a unique revenue path.
APEX is currently evaluating two unique 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
Following Canadian phase 2b study completion with demonstrated outcomes, APEX will pursue commercial approval in the US, Canada, UK, EU and Australia.
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 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.
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.
World’s largest take home microdose psilocybin clinical trial "PATHFINDER-52" approved 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 Q1 2024.
“SUMMIT-90” statistically powered 160 patient phase 2b clinical trial approved by Health Canada April 14th 2023 using APEX-90 macrodose drug product in-clinic with assisted psychotherapy. Pre-screening complete and trial launch Q4 2023.
With positive phase 2b data APEX will file for conditional approval (NOC/c) with Health Canada, moving to phase 3 studies seeking commercial approval in US, Canada, UK, EU and Australia.