If approved, the Apex-sponsored study will be conducted at the Yale School of Medicine using the DrivSim Lab’s DSRI miniSim research driving simulator.
Apex Labs said it has filed an IND application with the U.S. Food and Drug Administration (FDA) for a study aiming to support the development of its take-home microdose psilocybin, APEX-52.
If approved, the Apex-sponsored study will be conducted at the Yale School of Medicine using the DrivSim Lab’s DSRI miniSim research driving simulator.
Designed to enroll 55 participants, the goal of the study is 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,” explained principal investigator Barbara Banz from the 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,” Banz noted.
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,” said 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, added that the study “represents a significant leap forward in our mission to enhance patient care and safety in the use of our subperceptual microdose drug asset.”