Apex Labs Granted Approval for 160 Patient Macrodose Multi-Dose Psilocybin Clinical Trial by Health Canada

Apex Labs Ltd., a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, is pleased to announce approval of SUMMIT-90. SUMMIT-90 is a landmark double-blind, placebo controlled phase 2b study evaluating multiple doses of APEX-90 administered in-clinic with assisted psychotherapy for the treatment of severe depression within diagnosed PTSD. The 160 patient trial approval comes by way of a no objection letter received from Health Canada on April 14th, 2023 and the company aims to begin recruitment Q2 of 2023.

SUMMIT-90’s primary indication being studied is severe depression within diagnosed PTSD and secondary indications include standalone PTSD symptoms, chronic pain, and anxiety. APEX-90 will be administered multiple times during the study period in-clinic alongside assisted psychotherapy guided by the APEX proprietary therapy manual.

Currently it is estimated that over 8 million Canadians suffer from depression and 3.1 million navigate PTSD. Despite being the primary treatment for these conditions, studies estimate antidepressants only improved symptoms in around 20% of people, marking an important need for expanded therapeutic options.

“The APEX-90 dosing schedule was optimized for sustained efficacy based on gaps in the current market, focused on patients with the highest disease severity,” says Dr. Peter Tomlinson, Chief Medical Officer at APEX. “With two unique drug assets in the pipeline, APEX is able to address critical unmet need across mild, moderate and severe disease states.”

APEX has a microdose take home synthetic psilocybin drug asset, APEX-52 optimized for mild-to-moderate depression. The company recently completed a proof-of-concept trial meeting all clinical endpoints with no adverse events, and subsequently received approval for a 294 patient statistically powered phase 2b study, PATHFINDER-52, the largest of its kind in the world.

SUMMIT-90 and PATHFINDER-52 will be conducted through Centricity Research across five sites in Canada. APEX began patient pre-screening and recruitment in Q2 of 2023. Those interested in participating in clinical trials can sign up for updates at apexlabs.com/contact.

APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care for patients with clinically proven psilocybin treatments. By bringing data supported, clinically evaluated drugs to market for depression and anxiety in PTSD, APEX’s strategy is focused on developing pharmaceutical products through phased clinical programs evaluating safety and efficacy across multiple indications, alongside a robust early access program.

APEX sees Veterans as a patient base with the severest unmet need and strong mental healthcare infrastructure. APEX is supporting Veteran patients first and expanding to broader global patient communities.