Apex Labs
Apex Labs Ltd. is a private Canadian clinical-stage company developing psilocybin treatments for depression, anxiety, and PTSD, with a focus on the Veteran community. The company is advancing two parallel Phase 2b programmes: APEX-52 (take-home oral microdose psilocybin, the first of its kind in a Phase 2b trial) and APEX-90 (in-clinic macrodose psilocybin with assisted psychotherapy). Trials are running across Canada, the US (Yale School of Medicine PK study), and Israel (Tel Aviv University Sagol Brain Institute + Be'er Yaakov Mental Hospital, approved June 2025).
Drug Pipeline
2APEX-52
PsilocybinDepression and anxiety in PTSD (primarily Veterans). Take-home oral microdose psilocybin. STEP-52 proof-of-concept met all endpoints with no AEs. PATHFINDER-52 Phase 2b (n=294, Canada, randomised double-blind placebo-controlled) and APEX-002-B01-02 PK/driving simulator study at Yale (n=55) underway after FDA IND filed June 2024.
APEX-90
PsilocybinSevere depression and anxiety in PTSD. In-clinic macrodose psilocybin with assisted psychotherapy. SUMMIT-90 Phase 2b double-blind placebo-controlled trial active in Canada + Israel (Tel Aviv University Sagol Brain Institute and Be'er Yaakov Mental Hospital; Israeli MoH expansion approved June 2025).
Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase II
- HQ
- Canada, Canada
- Website
- Visit