Apex Labs Granted Approval for 294 Patient Take Home Psilocybin Clinical Trial

News provided by

Jan 19, 2023, 07:00 ET

The APEX-002-A01-03 randomized, double-blind, placebo-controlled phase 2b study plans to recruit patients across Canada to evaluate the efficacy, safety and tolerability of APEX-52, a microdose, orally administered synthetic psilocybin drug product in treating depression and anxiety among adults diagnosed with PTSD.

VANCOUVER, BC, Jan. 19, 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 its approval by Health Canada to begin APEX-002-A01-03, the world's largest take home psilocybin clinical trial approved to date. This randomized, double-blind, placebo-controlled phase 2b study will evaluate the efficacy, safety and tolerability of APEX-52 microdose, orally administered synthetic psilocybin drug product in treating depression and anxiety among adults diagnosed with Post-Traumatic Stress Disorder (PTSD). The approval comes by way of a No Objection Letter (NOL) from Health Canada received on January 5th 2023.

Image from Psygen (psygen.ca), one of the labs where the APEX-52 GMP API is manufactured (CNW Group/Apex Labs Ltd.)

"We are incredibly proud of the team for making APEX the first-mover in take home psilocybin treatment" Tyler Powell, APEX Chief Executive Officer comments. "Our focus is to execute a rigorous clinical pathway and positive results from APEX-002-A01-03 will allow APEX to move swiftly into phase 3 commercialization studies."

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 patient dosing.

APEX-002-A01-03 is a multi-centre, randomized, double-blinded, placebo-controlled trial aiming to recruit 294 adult subjects with depression and anxiety in diagnosed PTSD. Subjects not receiving placebo will be provided multiple doses of APEX-52 which will be self-administered in an outpatient setting. Efficacy will be evaluated against globally recognized scales for anxiety, depression, PTSD, and suicidality compared to baseline.

"After treating PTSD patients in my clinic for more than 20 years, we've seen the limitations of current treatments and the promise of psilocybin but more research is required," says Dr. Mark Johnston, APEX-002-A01-03 Principal Investigator and Director of Central Nervous System Research at Centricity Research. "This trial is significant as we are studying microdose psilocybin at a scale never done before. Microdoses are not associated with an intense psychedelic effect, allowing them to be taken at home and offering an easy to access, yet potentially equally effective pathway for psilocybin. Centricity has the facilities and operational expertise to begin a trial of this complexity swiftly."

Physician oversight will be present for the duration of the trial, with patients receiving regular check-ins during the study period.

Trial sites will be located in Ontario and Atlantic Canada. Recruitment will begin in the first half of 2023 and the trial will take place over the course of three months.

"As a Canadian company we are excited to conduct this trial in our own backyard," says Arron Victory, APEX Chief Strategy Officer and Canadian Armed Forces Veteran. "We have been incredibly pleased with Health Canada's efficient, thoughtful feedback and support across APEX submissions, exemptions and approvals."

APEX is a portfolio company of Iter Investments, with Managing Principal Dustin Robinson Esq. adding, "We have supported APEX since the early stages and are thrilled to see their hard work and our belief in the team pay off with this industry-changing approval."

To stay up to date on opportunities to participate in clinical research, corporate milestones and investment opportunities, subscribe for updates or contact the team directly at apexlabs.com/contact.

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.