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

VANCOUVER, BC, March 8, 2022 /CNW/ – 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 4th, 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.
 
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