Universal Ibogaine Inc (TSX-V:IBO) (UI) has introduced the expert partners, who will help the life sciences group in its bid to carry out a clinical trial in Canada for opioid use disorder.
The firm is currently working with its contract research organization (CRO) partners to finalize the study's design ahead of an expected pre-clinical trial application with Health Canada.
"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," said Nick Karos, Universal Ibogaine's CEO in a statement.
"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 with our partners' expertise, we will move towards our goal of conducting clinical trials with Health Canada," he added.
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Experienced Canadian firm Intrinsik Corp, which has contributed to over 20 new drug marketing applications, will provide regulatory strategy and support for the submission of the Canadian Clinical Trial Application (CTA), as well as follow-up and monitoring if a No Objection Letter (NOL) is received.
The operation of the clinical trial itself will come from world-class team at CATO Research Canada Inc (CATO SMS), said UI.
CATO SMS has successfully conducted more than 500 clinical trials in over 25 countries and has enrolled more than 60,000 patients at over 5,500 sites.
CATO SMS will also supply analysis and synthesis of proprietary real-world data and evidence (RWD and RWE (ETR:RWE) respectively], stemming from the application of ibogaine for the treatment of opioid use disorder in around 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 (ETR: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)," the company told investors.
"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," it added.
Contact the author at giles@proactiveinvestors.com