Apex Labs files IND with FDA for microdose psilocybin study

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Jun 20, 2024, 10:11 ET

VANCOUVER, BC, June 20, 2024 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin is pleased to announce the filing of an IND application with the U.S. Food and Drug Administration (FDA) for APEX-002-B01-02, a pioneering pharmacokinetics and driving simulator study of APEX-52 take home microdose psilocybin.

The study will be conducted at the Yale School of Medicine using their world-class DrivSim Lab's DSRI miniSim™ Research Driving Simulator, with APEX acting as the study sponsor. "Designed to enroll 55 participants, the study aims to shed light on crucial driving data and understand the pharmacokinetics of psilocybin—specifically, how long it takes for active blood levels to become undetectable," says Principal Investigator Barbara C. Banz, PhD from Yale School of Medicine. "Furthermore, it seeks to evaluate driving performance and vehicle control at Cmax to establish when patients can drive safely following dosing."

Findings from the study will be used to support the development of PATHFINDER-52, APEX's 294 patient phase 2b clinical trial using APEX-52 take home microdose psilocybin.

"This study is a cornerstone in terms of informing our phase 3 study design and our robust labeling strategy for APEX-52," says Greg Rutherford, Chief Commercial Officer at Apex Labs. "Patients taking the current standard of care in depression, SSRIs, are often recommended within the label to avoid driving or using heavy machinery until they are reasonably certain its ok to do so. Clear and measured understanding of the interaction between psilocybin and the ability to drive is fundamental for the safe integration of microdosing APEX-52 into patients' daily lives."

Tyler Powell, co-Founder and CEO of Apex Labs adds: "APEX is grateful for our collaborative partnership with Yale. We want patients taking our patent-pending APEX-52 capsule in the comfort of their own home to understand how they can integrate the treatment into their daily lives safely. This study represents a significant leap forward in our mission to enhance patient care and safety in the use of our subperceptual microdose drug asset."

About Apex Labs Ltd.

APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care with psilocybin. By bringing data supported, clinically evaluated drugs to market for depression in PTSD, APEX's strategy is focused on developing pharmaceutical products by evaluating safety and efficacy across multiple indications alongside a robust Early Access Program.

APEX sees Veterans as a patient base with the most severe unmet need, 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.

About the Yale Developmental Neurocognitive Driving Simulation Research Center (DrivSim Lab)
The Yale DrivSim Lab focuses on promoting safe driving by carrying out multidisciplinary research to understand driver behavior and identify factors that lead to motor vehicle crashes.

Visit: https://medicine.yale.edu/emergencymed/research/labs/drivsim/ for more information.

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 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: receiving of Health Canada Dealers Licence; filing US provisional patent, the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 (psilocybin) in treating depression in Veterans and patients with Post-Traumatic Stress Disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statements made by the Company's executives with respect to Health Canada's Dealer's Licence and capsule patent filing; the Company's efforts around the Early Access Program; statements made relating to Canadian Veteran patients; 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.