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Universal Ibogaine Inc. (TSXV: IBO) (" UI " or the " Company ") a life sciences company with a mission to develop and deliver medicalized ibogaine-centered addiction care, is pleased to introduce its contract research organization ("CRO") partners who will enable UI's planned clinical trial in Canada to be conducted, subject to the required approval by Health Canada. UI is currently working with its CRO partners to finalize UI's study design in advance of an anticipated pre-clinical trial application meeting to soon be held with Health Canada.
UI has selected Intrinsik Corp. (" Intrinsik "), 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 (" CTA" ), as well as follow-up and monitoring if a No Objection Letter ( "NOL" ) 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. (" CATO SMS "). 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.
Nick Karos - Universal Ibogaine CEO
Nick Karos (CEO) noted "Our engagement with Health Canada to date has clearly highlighted the road UI must take to provide practitioners and patients access to authorized ibogaine in Canada to treat opioid use disorder. The conduct of clinical trials is a very precise business requiring solid partnerships with the right expertise and players, and Universal Ibogaine is pleased that we have now secured these partnerships. We are confident that that with our partners expertise, we will move towards our goal of conducting clinical trials with Health Canada."
About Universal Ibogaine Inc.
UI is a life sciences company, with a mission to develop and acquire a network of addiction treatment clinics throughout Canada , and to eventually use ibogaine as a primary modality for the interruption and ideally cessation of addictions: primarily opioids such as oxycodone, heroin, fentanyl, as well as alcohol, cocaine, and other stimulants.
As such, UI concurrently plans to clinically develop ibogaine, a plant derived substance, as an authorized addiction interruption medicine for the treatment of Opioid Use Disorder. A Clinical Trial Application to Health Canada is being developed to undertake clinical trials in Canada , aimed at proving the safety and efficacy of the use of ibogaine for this purpose. In the longer term, and once approved as planned, UI will introduce ibogaine into the addiction treatment protocols to be used in its future facilities.
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such as "plans", "expect", "project", "intend", "will", "believe", "anticipate", "estimate", "scheduled", "potential", or other similar words, or statements that certain events or conditions "may", "should" or "could" occur. The forward-looking statements and information are based on certain key expectations and assumptions made by UI. Although UI believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because UI can give no assurance that they will prove to be correct.
Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks, which include, but are not limited to, risks that required regulatory approvals are not obtained. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable by UI at the time of preparation, may prove to be incorrect and readers are cautioned not to place undue reliance on forward-looking information, which speaks only to conditions as of the date hereof. UI does not undertake any obligation to release publicly any revisions to forward-looking information contained herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence of unanticipated events, except as may be required under applicable securities laws.
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Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)