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APEX is a patient-driven pharmaceutical company which develops and commercializes clinically evaluated psilocybin-derived treatments to tackle the most critical unmet need in depression, anxiety, and PTSD among Veterans and the general public. Our vision is to work with regulators and advocacy groups to expedite our clinical programs and data capture to facilitate broad access.
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Apex Labs Ltd. Our mission is to develop and commercialize clinically evaluated psilocybin-derived treatments to address the critical unmet needs in depression, anxiety, and PTSD among Veterans and the general public. We strive to expedite our clinical programs and data capture by collaborating with regulators and advocacy groups to ensure broad access to our treatments.
Despite being the current standard of care, studies show that antidepressants only improve symptoms in around half of the patients. At Apex Labs, we aim to provide a better solution. With 322 million people globally dealing with depression, 280 million suffering from PTSD, and a forecasted size of the anxiety disorder and depression treatment markets reaching $19.
5 billion USD by 2028, the market opportunity for our clinically proven psilocybin treatments is significant. Our commercial strategy involves developing and commercializing pharmaceutical assets that focus on addressing significant unmet needs across various patient segments. Currently, we are evaluating two unique drug assets seeking Health Canada Approval: the microdose drug candidate (APEX-52) for mild to moderate disease severity and the macro-dose drug candidate (APEX-90) with assisted psychotherapy for more severe disease.
Following the completion of a Canadian phase 2b study, APEX will pursue a regulatory pathway for commercial approval in the US, Europe, and Australia. We also prioritize Veteran patient communities, leveraging our network and relationships to ensure efficient recruitment of highly qualified patient candidates. Our clinical pathway includes the completion of the STEP-52 study, a proof-of-concept take-home microdose risk mitigation study.
We have also received approval for the PATHFINDER-52, the world's largest take-home microdose psilocybin clinical trial. Additionally, we have planned the SUMMIT-90 phase 2b clinical trial, which will use the APEX-90 macrodose drug product in-clinic with assisted psychotherapy. At Apex Labs, we are committed to revolutionizing mental health care by providing clinically proven treatments that address the critical unmet needs in depression, anxiety, and PTSD.
Stay informed about our approach and reach out to us for more information. Together, we can make a positive impact on mental health care
Company type
Privately Held
Year founded
2018
Company size
11-50 employees