Apex Labs submits IND to FDA for microdose psilocybin trial

June 20, 2024 - Apex Labs Ltd. (APEX), a pharmaceutical company at the forefront of mental health care innovation with psilocybin, has announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA). The application pertains to APEX-002-B01-02, a groundbreaking study focused on the pharmacokinetics and driving performance associated with APEX-52, a microdose psilocybin product.

The study will be hosted by Yale School of Medicine's DrivSim Lab, which will utilize its DSRI miniSim™ Research Driving Simulator. APEX is the study's sponsor. The research involves 55 participants and aims to gather essential data on driving performance and the pharmacokinetics of psilocybin. Principal Investigator Barbara C. Banz, PhD, from Yale School of Medicine, explained that the study seeks to determine how long psilocybin remains detectable in the blood and to evaluate driving capabilities at peak concentration levels (Cmax). The ultimate goal is to ascertain when it is safe for patients to drive post-dosing.

The data obtained from this study will be instrumental in the development of PATHFINDER-52, a phase 2b clinical trial targeting 294 patients and utilizing APEX-52 microdose psilocybin. Greg Rutherford, Chief Commercial Officer at Apex Labs, emphasized the importance of this study for designing phase 3 trials and formulating a robust labeling strategy for APEX-52. He noted that patients currently taking selective serotonin reuptake inhibitors (SSRIs) for depression are often advised against driving or operating heavy machinery until they can reasonably ascertain their safety. Therefore, a clear understanding of how psilocybin affects driving is crucial for safely incorporating APEX-52 into patients' daily routines.

Tyler Powell, co-founder and CEO of Apex Labs, expressed gratitude for the collaboration with Yale. He highlighted that the study is a significant step towards ensuring that patients can safely integrate APEX-52 microdosing into their everyday lives. Powell underscored the company's commitment to enhancing patient care and safety with their subperceptual microdose drug asset.

Apex Labs Ltd. is dedicated to transforming mental health care standards with psilocybin. The company focuses on developing clinically evaluated drugs for depression and PTSD, with a strategy centered around safety and efficacy across multiple indications. Apex also prioritizes supporting veterans, who often have the most severe unmet needs, and plans to expand its reach to a broader global patient base.

The Yale Developmental Neurocognitive Driving Simulation Research Center (DrivSim Lab) is renowned for its multidisciplinary research aimed at promoting safe driving. The lab studies driver behavior and identifies factors contributing to motor vehicle accidents.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!