Biopharma company Apex Labs Ltd. has completed one of the first take-home microdose psilocybin clinical trials, meeting all study endpoints over a two-month period with no adverse events reported.
CEO Tyler Powell called it a clinical milestone and said he’s certain it will help the company’s position as a first mover in take-home psilocybin treatment while advancing its commitment to treating “the substantial unmet need” within the Veteran community.
The Health-Canada-approved study, which began in January and completed patient dosing on March 29, seeks safety, efficacy and tolerability of take-home proprietary GMP-compliant synthetic psilocybin APEX-52 in veterans with PTSD-related depression.
The trial also assessed the stability of symptoms when transitioning from illicit unregulated psilocybin to regulated APEX-52.
APEX was granted approval to commence a 294-participant Phase 2b take-home microdose clinical trial, the largest approved to date, to evaluate the efficacy, safety and tolerability of APEX-52 in treating depression and anxiety among adults with PTSD.
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