⚕️ Apex Labs Files IND with FDA for Microdose Psilocybin Study

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Tuesday, 25 June 2024 02:33.PM

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."

SOURCE: Apex Labs Ltd.

*** This release contains certain "forward-looking statements"
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