Universal Ibogaine Inc (TSX-V:IBO) said it has entered into an agreement with Psygen Labs to secure a supply of good manufacturing practice (GMP) ibogaine for use in its planned future clinical trial for opioid use disorder and ongoing ibogaine detox treatments at its clinics.
The company noted that it is in the process of finalizing its pre-clinical trial (pre-CTA) submission to Health Canada, following which it intends to apply to undertake a clinical trial of ibogaine for use in treatment of opioid use disorders.
The final approval by Health Canada will require it to have an approved, secure supply of GMP certified ibogaine to use in the eventual clinical trial process, it added.
READ: Universal Ibogaine introduces its CRO partners ahead of potential clinical trial for opioid use disorder in Canada
"We are pleased to have secured a firm of Psygen's caliber as one of our key partners,” the company’s CEO Nick Karos said in a statement.
“Ibogaine has been used in tribal ceremonies in Africa for centuries and has traditionally been sourced for medical use from the root bark of a shrub found in limited areas of the Congo basin in Africa. Psygen has developed a process to manufacture synthetic ibogaine, which will provide a more secure and sustainable source of supply for our trials and a scalable solution for our treatment protocol to help as many people as possible."
Psygen is a Canadian company based in Calgary and is a leader in the manufacture of a range of medical-grade products being used in the emerging psychedelics-based psycho-therapy field of treatment of anxiety, depression and other mental health issues.
Universal Ibogaine said the agreement with the company covers basic terms as to pricing, manufacture, and delivery of ibogaine. A definitive drug supply agreement is to be finalized soon, incorporating such factors as the volume of ibogaine that will be required, based on the ultimate size of the patient group required for the planned clinical trials.
“We look forward to a long-term partnership with Psygen as part of our goal of having ibogaine approved for wide-scale use in opioid detoxification and addiction treatments,” Karos concluded.
Universal Ibogaine is a life sciences company, with a mission to demonstrate the safety and efficacy of its ibogaine-based drug detox protocol through a Canadian Clinical Trial, and ultimately to utilize that protocol around the globe through future licensing agreements.
The company is concurrently developing a state-of-the-art holistic addiction treatment protocol at its Kelburn Clinic that, when paired with the ibogaine detox protocol, is intended to revolutionize the way addiction is treated, improving the lives of individuals and families affected by addiction.
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