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Apex Labs Begins Clinical Trial for Take-Home Psilocybin
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.”
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