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Apex Labs Begins Clinical Trial for Take-Home Psilocybin

Tom Valentino, Digital Managing Editor

Apex Labs, a pharmaceutical company specializing in the optimization of mental healthcare treatment services using psilocybin, announced that it has commenced patient dosing in a Phase 2b take-home, multi-dose psilocybin clinical trial.

The trial, which was approved by the regulatory agency Health Canada, is evaluating APEX-52, a synthetic psilocybin formulation to treat depression and anxiety in veterans who have been diagnosed with post-traumatic stress disorder. Specifically, the trial is designed to evaluate the safety and efficacy of APEX-52 and the stability of symptoms experienced by veteran patients who are transitioning from unregulated psilocybin to the regulated, orally administered synthetic.

In a news release announcing the trial’s launch, Apex CEO Tyler Powell called the study “a watershed moment for psilocybin research.”

“We know veterans are self-medicating with microdoses of unregulated psilocybin products,” Powell said. “For the first time in North America, a patient will be able to take a pharmaceutical-grade microdose psilocybin drug product from the comfort of their own home. This trial will inform future Phase 3 clinical study design and protocol development for intended commercialization.”

 

Reference

Apex Labs doses first patient in take home psilocybin clinical trial. News release. Apex Labs. January 18, 2023. Accessed January 23, 2023.

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