Proof of concept STEP-52 trial shows treatment efficacy and stability of PTSD symptoms when moving from unregulated drug to APEX-52 GMP drug product.
VANCOUVER, BC, March 29, 2023 /CNW/ – Apex Labs Ltd. (APEX or the Company), 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,” says APEX CEO Tyler Powell. “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.”
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.
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.
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This release contains certain “forward looking statements” and certain “forward-looking information” as defined under applicable Canadian securities laws. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “continue”, “plans” or similar terminology. Forward-looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause the Company’s actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: Details of the STEP-52 trial, the Company administering the first take home multi-dose psilocybin clinical trial in Canada; the Company evaluating the safety and efficacy of APEX-52 (psilocybin) in treating depression within diagnosed post-traumatic stress disorder; statements related to APEX-52 has a microdose, multi-dose, take-home orally administered psilocybin drug product, manufactured in accordance with Good Manufacturing Practices and currently formulated, packaged, and labeled for self-administered patient dosing in the home; statements made by the Company’s CEO with respect to the being a first mover in take home psilocybin treatment, and their commitment to tackling the substantial unmet need within the Veteran community; statements relating to North American regulatory bodies are taking necessary steps in accelerating patient’s path to medical access; statement’s made relating to Canadian Veteran patient’s taking APEX-52 in the comfort of their own home; the potential impact of epidemics, pandemics or other public health crises, including the current outbreak of the novel coronavirus known as COVID-19 on the Company’s business, operations and financial condition, the successful integration of technology, the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward-looking information except as required by applicable law. Such forward-looking information represents managements’ best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information.
SOURCE Apex Labs Ltd.
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