Apex Labs has received no objection letter from Health Canada for its SUMMIT-90 Phase IIb study of APEX-90, designed to treat severe depression within diagnosed post-traumatic stress disorder (PTSD).
Patient recruitment for the trial is expected to commence in the second quarter of this year.
The study will investigate 160 patients with multiple APEX-90 doses given in-clinic with assisted psychotherapy.
Primary indication of the trial is to study severe depression within diagnosed PTSD. Standalone PTSD symptoms, chronic pain, and anxiety are secondary indications.
Apex Labs co-founder and CEO Tyler Powell said: “This approval validates the urgent need for expanded healthcare options and ultimately gives physicians another tool to support patients struggling with depression and PTSD.
“We already have first movers advantage in take home microdose psilocybin treatment and SUMMIT-90 expands the Apex drug portfolio to address the current inadequate standard of mental health care.”
The home synthetic psilocybin APEX-52 treats mild-to-moderate depression.
The company’s 294-patient Phase IIb PATHFINDER-52 study recently received approval.
Both studies are being conducted through Centricity Research across five Canadian sites.
Apex chief medical officer Dr Peter Tomlinson said: “With two unique drug assets in the pipeline, Apex is able to address critical unmet need across mild, moderate and severe disease states.”