APEX-002-A01-02 will evaluate the safety and efficacy of APEX-52 low dose, multi-dose synthetic psilocybin drug product in treating depression in Veterans with PTSD
VANCOUVER, BC, Nov. 1, 2022 /CNW/ - Apex Labs Ltd. ("APEX" or the "Company"), a pharmaceutical company optimizing the standard of mental health care for Veterans, is pleased to announce its approval for the first North American take home multi-dose psilocybin clinical trial, APEX-002-A01-02, evaluating the safety and efficacy of APEX-52 (psilocybin) in treating depression in Veterans with Post Traumatic Stress Disorder ("PTSD"). This approval comes by way of a No Objection Letter ("NOL") from Health Canada received on October 24th, 2022. APEX-52 is a low dose, multi-dose, orally administered psilocybin drug product, manufactured under Good Manufacturing Practice ("GMP"), and currently formulated, packaged, and labeled for self-administered patient dosing in the home.
Tyler Powell, APEX Chief Executive Officer comments, "this approval signals a willingness from Health Canada to allow APEX to move forward with a clinical pipeline focused on Veteran patients with PTSD and a comorbid diagnosis of depression. Veterans are already self-medicating with micro-doses of unregulated psilocybin products without knowing the potency and safety of the product they are consuming. Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need."
Psilocybin has demonstrated clinical benefit in a variety of disorders and North American regulatory bodies are taking necessary steps in accelerating patient's paths to medical access. Psilocybin recently received breakthrough designation from the United States Food and Drug Administration ("FDA") for its potential treatment of depression, and Health Canada broadened the Special Access Program ("SAP") on January 5th, 2022 to include psilocybin and MDMA.
Mr. Powell adds, "it is beyond satisfying to know that our team's hard work has led to the first Canadian Veteran patient taking APEX-52 in the comfort of their own home."
About Apex Labs Ltd.
Apex Labs Ltd. is a patient-driven pharmaceutical company focused on optimizing the standard of mental health care for Veterans by bringing data supported, clinically evaluated psilocybin-derived drugs to market for depression in PTSD. APEX is focused on Veterans, who suffer from PTSD at a substantially higher rate than the general public and struggle to find relief from the current inadequate standard of care. APEX's strategy is focused on developing pharmaceutical products through a robust phased clinical program, while evaluating safety and efficacy in a real-world setting by simultaneously working with Veterans and their primary Health Care Practitioners ("HCP") to develop effective channels to get patients the medical care they need.
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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.