Apex Labs Doses First Patient in Take Home Psilocybin Clinical Trial

News provided by

Jan 18, 2023, 13:55 ET

Canadian Veteran takes APEX-52, microdose, orally administered psilocybin drug product during APEX-002-A01-02 trial

VANCOUVER, BC, Jan. 18, 2023 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company optimizing the standard of mental health care with psilocybin, is pleased to announce the commencement of patient dosing in APEX-002-A01-02, a phase 2b take home multi-dose psilocybin clinical trial approved in October of 2022 by Health Canada. The trial will evaluate APEX-52 (psilocybin) in treating depression and anxiety in diagnosed Post Traumatic Stress Disorder (PTSD) within the Veteran community.

This trial is specifically designed to evaluate the safety and efficacy of APEX-52 and the stability of symptoms experienced by a Veteran patient transitioning from illicit unregulated psilocybin to regulated APEX-52 synthetic psilocybin.

"This is a watershed moment for psilocybin research," says APEX CEO Tyler Powell. "We know Veterans are self-medicating with microdoses of unregulated psilocybin products. For the first time in North America, a patient will be able to take a pharmaceutical grade microdose psilocybin drug product from the comfort of their own home. This trial will inform future phase 3 clinical study design and protocol development for intended commercialization."

APEX-52 is a microdose, orally administered psilocybin drug product dosed regularly per the study protocol, manufactured under Good Manufacturing Practices (GMP) which is currently formulated, packaged, and labeled for self-administered dosing.

About Apex Labs Ltd.

APEX is a patient-driven pharmaceutical company focused on optimizing the standard of mental health care with psilocybin 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 a phased clinical program 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: Health Canada's non-objection to clinical trial application protocol APEX-002-A01-02; the Company administering the first take home multi-dose psilocybin clinical trial in Canada; the Company evaluating the safety and efficacy of APEX-52 (psilocybin) in treating depression in Veterans with depression in post-traumatic stress disorder; statements related to APEX-52 has a low dose, multi-dose, orally administered psilocybin drug product, manufactured in accordance with Good Manufacturing Practices and currently formulated, packaged, and labeled for self-administered patient dosing in the home; statement's made by the Company's CEO with respect to the Company's goal to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need; statements relating to North American regulatory bodies are taking necessary steps in accelerating patient's path to medical access; 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.