Transforming mental health care with 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 visionis 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
Despite being the current standard of care treatment for depression, anxiety 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
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).
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
Macrodose drug candidate (APEX-90) positioned for in-clinic dosing with assisted psychotherapy targeting more severe disease
Following Canadian phase 2b study completion with demonstrated outcomes, APEX will pursue a regulatory pathway towards commercial approval in the US, Europe 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 completed patient dosing in a proof-of-concept take home microdose risk mitigation study using APEX-52 drug product, the first of its kind. The trial completed March 29th 2023 and met all endpoints over a two month period with no adverse events.
World’s largest take home microdose psilocybin clinical trial "PATHFINDER-52" approved by Health Canada January 3rd 2023. 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 Q4 2023.
“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 in progress and trial launch Q4 2023.
Following Canadian phase 2b study completion with demonstrated outcomes, APEX will challenge regulatory agencies for pre-phase 3 conditional approval expanding towards commercial approval in Canada, US, Europe and Australia.