Canadian Veteran Receives Approval for APEX's Psilocybin Therapy Through Health Canada's Special Access Program

Veteran to receive APEX-90 macrodose psilocybin drug product in combination with assisted psychotherapy consistent with SUMMIT-90 clinical trial protocol.

VANCOUVER, BC, Sept. 27, 2023 /PRNewswire/ - 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," says the Canadian Armed Forces Veteran who received the approval. "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." 

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," says Arron Victory, APEX Co-Founder and Chief Strategy Officer. "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."

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 14^th 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.

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.

Visit apexlabs.com for more information and follow APEX on LinkedIn, Twitter and Instagram

Forward-Looking Statement
This release contains certain "forward looking statements" and certain "forward-looking information" as defined under applicable Canadian securities laws. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "continue", "plans" or similar terminology. Forward-looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: Permit approvals from Health Canada, the Drug Enforcement Administration (DEA), and US customs, Health Canada's CTA amendments, the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 (psilocybin) in treating depression in Veterans with depression in post-traumatic stress disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statements made by the Company's CEO with respect to the Company's efforts to enter the US market and file an IND; statements from the Company's CSO relating to their drug development and secondary manufacturer; statements made relating to Canadian Veteran patients using APEX-52 in the comfort of their own home; the potential impact of epidemics, pandemics or other public health crises, including the COVID-19 pandemic, on the Company's business, operations and financial condition, the successful integration of technology, the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward-looking information except as required by applicable law. Such forward-looking information represents managements' best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information.

SOURCE Apex Labs Ltd.