UI has selected Intrinsik Corp., an internationally recognized regulatory affairs consulting firm, to provide regulatory strategy and support for the preparation and submission of UI’s Canadian Clinical Trial Application, as well as follow-up and monitoring if a No Objection Letter is received from Health Canada. Intrinsik is comprised of an experienced team who have driven hundreds of successful clinical trials and investigational new drug applications and have collectively contributed to more than 20 new drug marketing applications. The group has over 25 regulatory affairs professionals based in its Canadian headquarters located in the greater Toronto area, and unparalleled expertise and experience related to Central Nervous System Disorders (CNS: the therapeutic area to which addiction and mental health disorders belong).
Support for the development of the substance of the CTA package, as well as ultimately the operation of the clinical trial itself, is being provided by the world-class team at CATO Research Canada Inc. The CATO SMS team of experts have over 30-years’ experience optimizing the design and execution of clinical trials for life sciences companies such as UI. CATO SMS has successfully conducted over 500 clinical trials in over 25 countries and have enrolled more than 60,000 patients at over 5,500 sites.
The CATO SMS engagement team, along with UI’s team, involves a variety of experts in Canada, the US and Europe, providing critical expertise ranging from clinical study designs to biostatistics to clinical operations (e.g., patient recruitment, study startup, budgeting, site management, data management, etc.). CATO SMS’ contributions will also include the analysis and synthesis of proprietary real-world data and evidence ( “RWD” and “RWE”, respectively) stemming from the application of ibogaine for the treatment of opioid use disorder in approximately 200 patients who have been treated in Cancun, Mexico by UI’s licensing partner – Clear Sky Recovery Cancun SA de CV. UI believes that the presentation of RWD and RWE as part of the CTA package will strengthen the application, particularly the preliminary claim to safety, and is aligned with emerging guidance by regulators, such as the US Food and Drug Administration (“FDA”), to acknowledge and incorporate RWD and RWE in clinical development, and generally in evidence-based medicine.
Finally, UI is lining up prominent academic and medical centres to support the CTA to Health Canada, as well as potentially serve as sites to undertake the ultimate clinical trial. Notably, UI has engaged the research office of a leading Canada-based academic and teaching institution in the therapeutic area of addiction to support the design of the study protocol and generate interest in trial site selection.