Apex Labs Submits FDA Application for Microdose Psilocybin Study

Credit: US Food and Drug Administration

Apex Labs filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for APEX-52, a microdose, orally administered synthetic psilocybin to treat PTSD. The filing was announced on June 20, 2024.

At-home APEX-52 will be evaluated in the pharmacokinetics and driving simulator study, APEX-002-B01-02, conducted at Yale School of Medicine. Investigators will use their world-class DrivSim Lab’s DSRI miniSim Research Driving Simulator, designed to identify factors that might lead to motor vehicle crashes.

“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," said lead investigator Barbara C. Banz, PhD from Yale School of Medicine, in a press release. "Furthermore, it seeks to evaluate driving performance and vehicle control at Cmax to establish when patients can drive safely following dosing."

Apex works toward evaluating the efficacy and safety of drugs to market for depression in patients with PTSD. Ultimately, this study will help support the development of PATHFINDER-52 (APEX-002-A01-02), a randomized, double-blind, placebo-controlled phase 2b trial with 294 Canadian evaluating the efficacy, safety, and tolerability of take-home APEX-52 to treat depression and anxiety in adults with PTSD.

“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, in a press release. "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."

References

1. ^{Apex Labs Files IND with FDA for Microdose Psilocybin Study. PR Newswire. June 20, 2024. https://www.prnewswire.com/news-releases/apex-labs-files-ind-with-fda-for-microdose-psilocybin-study-302178089.html. Accessed June 20, 2024.}
2. ^{Apex Labs Granted Approval for 294 Patient Take Home Psilocybin Clinical Trial. Cision. January 19, 2023. https://www.newswire.ca/news-releases/apex-labs-granted-approval-for-294-patient-take-home-psilocybin-clinical-trial-881074976.html. Accessed June 20, 2024.}