Apex Labs Files IND Application for APEX-52 Study of Take-Home Microdose Psilocybin

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The outcomes of this study are expected to inform the development of the upcoming PATHFINDER-52 phase 2b clinical trial.

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Microgen_AdobeStock

Apex Labs Ltd announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for APEX-002-B01-02, a study that will investigate the pharmacokinetics and driving performance related to the company’s APEX-52 take-home microdose psilocybin.1

The study is set to be conducted at the Yale School of Medicine’s DrivSim Lab, utilizing the lab’s DSRI miniSim™ research driving simulator. Apex Labs, a pharmaceutical company focused on advancing mental health care through the use of psilocybin, will act as the study sponsor.1

“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 the study’s principal 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.”

The outcomes of this study are expected to inform the development of PATHFINDER-52, APEX’s upcoming phase 2b clinical trial involving 294 patients using APEX-52 take-home microdose psilocybin,1 which has shown efficacy in recent research in the improvement of symptoms of mental health disorders such as posttraumatic stress disorder (PTSD)2 and major depressive disorder (MDD).3

“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, [selective serotonin reuptake inhibitors] (SSRIs), are often recommended within the label to avoid driving or using heavy machinery until they are reasonably certain it is 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, expressed gratitude for the collaboration with Yale.1 “Our partnership with Yale is instrumental in helping patients understand how to safely integrate APEX-52 into their routines,” Powell said in a press release. “This study marks a significant step forward in our mission to improve patient care and safety with our microdose psilocybin treatment.”

According to Apex Labs, as the study progresses, the findings will play a critical role in the broader development and regulatory approval process for APEX-52, potentially setting new standards in mental health care treatment protocols.1

Are you interested in learning more about the latest research and developments on psilocybin and other psychedelics for the treatment of PTSD, MDD, and other psychiatric disorders? See these and more expert discussions in Psychiatric Times®:

Phase 2 Study of COMP360 Psilocybin Finds Improved PTSD Symptoms

Medication-Assisted Psychotherapy: The Past and Future of Psychiatry

Single-Dose Psilocybin for Treatment-Resistant Major Depression

The Gut-Brain Connection: An Upcoming Study on Psilocybin-Assisted Psychotherapy and Irritable Bowel Syndrome

Lykos Therapeutics Releases Statement on FDA Advisory Committee Meeting

FDA Grants Breakthrough Designation to MM-120 for Generalized Anxiety Disorder

Psilocybin Plus SSRIs for Treatment-Resistant Major Depression

Ketamine and Psychedelics: The Journey From Magical Mystery to Informed Consent

Navigating New Terrain: Clinician Education at the Crossroads of Psychedelics and Medical Ethics

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of other psychiatric disorders at psychiatrictimes.com.

References

1. Apex Labs files IND with FDA for microdose psilocybin study. PR Newswire. News release. June 20, 2024. Accessed June 20, 2024. https://www.prnewswire.com/news-releases/apex-labs-files-ind-with-fda-for-microdose-psilocybin-study-302178089.html

2. Duerr HA. Phase 2 study of COMP360 psilocybin finds improved PTSD symptoms. Psychiatric Times. May 9, 2024. Accessed June 20, 2024. https://www.psychiatrictimes.com/view/phase2-study-of-comp360-psilocybin-finds-improved-ptsd-symptoms

3. Miller B. Single-dose psilocybin for treatment-resistant major depression. Psychiatric Times. October 2, 2023. Accessed June 20, 2024. https://www.psychiatrictimes.com/view/single-dose-psilocybin-for-treatment-resistant-major-depression

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