Veteran to receive APEX-90 macrodose psilocybin drug product in combination with assisted psychotherapy consistent with SUMMIT-90 clinical trial protocol.
Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin treatments is excited to announce that a physician has been authorized to receive APEX-90 macrodose psilocybin drug product via Health Canada’s Special Access Program (SAP) for the treatment of a Canadian Armed Forces Veteran suffering from Treatment Resistant Depression (TRD). Dosing is expected October 2023. The patient will be taking APEX-90 macrodose psilocybin with assisted psychotherapy following APEX’s Investigator Brochure (IB) and Therapy Manual (TM) aligned with the protocol outlined in its Health Canada approved 160 patient phase 2b SUMMIT-90 statistically powered clinical trial, which recently completed patient pre-screening.
“Every Veteran matters but we are often left behind. I have been following existing standards of care for my depression and PTSD for a decade, and it just hasn’t been enough. The process to get an SAP was difficult but it is all we have to access these essential emerging treatments. I am grateful to the APEX team and my physician for moving this forward and hope more Veterans like me will gain access.”
-The Canadian Armed Forces Veteran who received the approval
Currently the primary mechanism through which Health Canada allows psilocybin access outside of clinical trials is the SAP. It allows health care professionals to access drugs of potential benefit that are not marketed or authorized for sale in Canada. The SAP is only available for treatment of patients with serious or life-threatening conditions when conventional therapies have failed.
“We are proud to have supported this SAP application from beginning to end and grateful for Health Canada’s guidance through the process. This aligns with APEX’s vision to prioritize the Veteran Community as a key step towards broader access. We are committed to providing early access to Veterans alongside our traditional clinical program.”
-Arron Victory, APEX Co-Founder and Chief Strategy Officer
APEX successfully supported Canada’s first psilocybin SAP approval with its IB to treat six patients experiencing end-of-life distress in April of 2022. The Company plans on supporting additional SAP applications for physicians who are interested in accessing APEX psilocybin for their Veteran patients beginning in 2024.
The SUMMIT-90 clinical trial is designed to investigate the safety and efficacy of APEX-90 for treatment of severe depression within diagnosed PTSD. Market authorization of APEX-90 has not been granted by Health Canada or other drug product regulators, and as a result APEX-90 is eligible for access in Canada through the SAP.
SUMMIT-90 is a statistically powered multi-centre randomized, double-blind, placebo-controlled phase 2b study of a macrodose psilocybin drug asset approved by way of a No Objection Letter (NOL) from Health Canada received on April 14th 2023. SUMMIT-90 evaluates multiple doses of APEX-90 macrodose psilocybin administered in-clinic with assisted psychotherapy for the treatment of severe depression in patients with diagnosed PTSD, recruiting 160 patients in Canada.
SUMMIT-90’s primary indication being studied is severe depression within diagnosed PTSD, and secondary indications include standalone PTSD symptoms, chronic pain, and anxiety.
About the Special Access Program (SAP)
In Canada, the SAP allows healthcare practitioners to access non-marketed or unauthorized drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or unavailable. To obtain access, the healthcare practitioner must submit a request to Health Canada detailing the medical rationale for the use of the drug, after which, if approved, the drug can be acquired directly from the manufacturer or another supplier authorized by Health Canada.
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 most severe unmet need, supporting Veteran patients first and expanding to broader global patient communities.