Apex Labs granted phase 2a Clinical Trial Application approval by Health Canada for treatment of PTSD in Veterans

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Mar 08, 2022, 08:35 ET

VANCOUVER, BC, March 8, 2022 /PRNewswire/ - Apex Labs Ltd. ("Apex", or the "Company"), a socially focused pharmaceutical company, is pleased to announce the receipt of a No Objection Letter ("NOL") from Health Canada regarding its phase 2a Clinical Trial Application ("CTA") protocol APEX-002-A01-01 on March 4^th, 2022. This CTA approval is for a randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability and efficacy of psilocybin in Veterans with post-traumatic stress disorder using drug product APEX-002-A01. Apex has secured its Veteran patient base, clinical trial location and Qualified Investigator for its phase 2a program expected to launch as early as Q2/Q3 2022.

Apex's CEO and Director Tyler Powell echoes the founding partners sentiment, "The team at Apex Labs has worked tirelessly to achieve this milestone and believe our company has quietly positioned itself to be a leader in the North American psychedelics space through a strategy utilizing our clinical expertise, connection to veteran patients and our commitment to broader access to regulated psychedelic drug products for therapeutic benefit."

About Apex Labs Ltd.

Apex's clinical development program is focused on Veterans – a population disproportionately affected by mental health conditions. The Company's lead clinical candidate is a low-dose synthetic psilocybin product for the treatment of Post-Traumatic Stress Disorder ("PTSD") and treatment resistant depression.

Apex's strategy is to develop drug products including Active Pharmaceutical Ingredients ("API") produced by chemical synthesis, and also drug products with botanically sourced API, differentiating Apex by diversifying Apex's options for development and commercialization of drug products.

For more information on Apex, please visit us at https://apexlabs.com/

‎Forward-Looking Statements

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: the randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability and efficacy of psilocybin in Veterans with post-traumatic stress disorder using drug product APEX-002-A01; the Company securing its Veteran patient base, clinical trial location and Qualified Investigator for its phase 2a program expected to launch as early as Q2/Q3 2022; the Company's lead clinical candidate is a low-dose synthetic psilocybin product for the treatment of PTSD and treatment resistant depression; the Company's strategy to develop drug products including API produced by chemical synthesis, and also drug products with botanically sourced API, differentiating Apex by diversifying Apex's options for development and commercialization of drug products; 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.