Apex Labs Receives Approval for US-Based Secondary GMP Psilocybin Supplier by Health Canada

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Jun 09, 2023, 11:56 ET

Imported GMP API across Canadian-US Border
Establishes supply chain stability in Canada and large US pharmaceutical market

VANCOUVER, BC, June 9, 2023 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, announces Health Canada Approval of the company's secondary US-based supplier of Good Manufacturing Practices (GMP) psilocybin Active Pharmaceutical Ingredient (API) in addition to its existing primary Canadian-based supplier. APEX is actively shipping drug through its licensed contractors across the Canadian-US border with permit approvals from Health Canada, the Drug Enforcement Administration (DEA), and US customs.

APEX Synthetic Psilocybin Capsules (CNW Group/Apex Labs Ltd.)

"This is a large step forward for our drug development program," says Dr. Orion Lekos, APEX Co-Founder and Chief Science Officer. "Securing a second GMP drug manufacturer gives us two sources of API creating a sustainable supply of drug product to support our planned clinical programs in the US and Canada."

Health Canada authorization was received for the secondary manufacturer by way of a Clinical Trial Application (CTA) amendment.

"The United States represents half of the global pharmaceutical market. Following years of partnership development and effort by the APEX team, this facilitates our ability to successfully execute clinical trials and our Early Access Program in Canada and the US with drug supply established in both markets," says Tyler Powell, APEX Co-Founder and CEO. "As a result of our positive clinical progression with Health Canada, APEX is now executing our US regulatory strategy by filing an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) in 2023 leveraging our regulatory submissions with Health Canada."

About APEX Clinical Studies:

PATHFINDER-52 and SUMMIT-90 are statistically powered multi-centre randomized, double-blind, placebo-controlled phase 2b studies leveraging microdose and macrodose psilocybin drug assets.

APEX intends to optimize the two unique drug assets to target mild, moderate and severe disease across intended indications, addressing significant unmet clinical need.

PATHFINDER-52 evaluates multiple regular doses of APEX-52 microdose, take-home orally administered synthetic psilocybin drug product in treating depression and anxiety in patients with diagnosed Post-Traumatic Stress Disorder (PTSD), recruiting 294 subjects, the world's largest take home psilocybin clinical trial approved to date.

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 Apex Labs Ltd.

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.

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 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; statement's 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; statement's made relating to Canadian Veteran patient's taking APEX-52 in the comfort of their own home; the potential impact of epidemics, pandemics or other public health crises, including the current outbreak of the novel coronavirus known as COVID-19 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.