Apex Labs Ltd., a pharmaceutical company optimizing the standard of mental health care with clinically proven psilocybin treatments, is pleased to announce the completion of the first-ever take home microdose psilocybin clinical trial, meeting all endpoints over a two month period with no adverse events. STEP-52 (risk mitigation study evaluating take home synthetic psilocybin) was specifically designed to evaluate the safety, efficacy, and tolerability of APEX-52 for the treatment of depression in patients diagnosed with Post Traumatic Stress Disorder (PTSD) within the Veteran community. The study also evaluated the stability of symptoms when transitioning from illicit unregulated psilocybin to regulated APEX-52 synthetic psilocybin.
“This clinical milestone cements APEX as the first mover in take home psilocybin treatment and furthers our commitment to treating the substantial unmet need within the Veteran community. Following our recent approval for the world’s largest take home microdose clinical trial, STEP-52 confirms we are on the right track towards demonstrating efficacy of this new drug in pivotal clinical trials.”
APEX CEO Tyler Powell
STEP-52 was approved by Health Canada in October of 2022, commenced January of 2023, and patient dosing was completed March 29th, 2023.
In January, APEX also received approval for a 294-participant phase 2b take home microdose clinical trial, PATHFINDER-52, the largest approved to date, which will evaluate the efficacy, safety and tolerability of APEX-52 in treating depression and anxiety among adults diagnosed with PTSD.
APEX-52 is a microdose, orally administered psilocybin drug product dosed regularly per the study protocol, manufactured under Good Manufacturing Practices (GMP) which is currently formulated, packaged, and labeled for self-administered dosing.
About Apex Labs Ltd.
APEX is a patient-driven pharmaceutical company focused on optimizing the standard of mental health care with clinically proven psilocybin treatments by bringing data supported, clinically evaluated drugs to market for depression and anxiety in PTSD. APEX’s strategy is focused on developing pharmaceutical products through a phased clinical program evaluating safety and efficacy across multiple indications, alongside a robust early access program.
APEX sees Veterans as a patient base with the most severe unmet need and strong mental healthcare infrastructure. APEX is supporting Veteran patients first and expanding to broader global patient communities.