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Agreement to carry out Phase 1 cannabinoid medicine clinical trials

Home » Agreement to carry out Phase 1 cannabinoid medicine clinical trials

Oxford Cannabinoid Technologies’ Phase 1 first-in-human clinical trial will be carried out in the UK in healthy volunteers. 

The trial will use Oxford Cannabinoid Technologies’ lead compound, OCT461201. OCT461201 is a selective cannabinoid receptor type 2 agonist which has shown potential as an effective therapy for chemotherapy-induced peripheral neuropathy as well as irritable bowel syndrome.

Read more: Further drug development agreement for Oxford Cannabinoid Technologies

The trial is set to begin Q1 2023 following regulatory submission to the UK Medicines & Healthcare products Regulatory Agency (MHRA), with interim results expected by the end of March 2023 and the full report expected in Q2 2023.

The trial will use a single ascending dose and is aimed at demonstrating the safety and tolerability of the drug product, while providing pivotal information on the pharmacokinetic profile of OCT461201 to confirm its value as a potential drug. 

CEO of OCTP, Dr John Lucas, said: “We are very excited to partner with Simbec-Orion as we progress our drug candidates to the next crucial phase of their development – randomised, controlled clinical trials. 

“This work with Simbec-Orion helps the company deliver the targets we set out in our prospectus and meets the quality standards we set to safeguard patients.

“This is an important step along the development path for OCT461201, as we advance into clinical trials in healthy volunteers, getting us closer to the aim of providing a much-needed safe and effective pain treatment for patients whilst also, ultimately, generating value for shareholders.”

Simbec-Orion is an award winning, full-service clinical research organisation with over 45 years’ specialist expertise in clinical pharmacology and lab expertise and over 25 years’ clinical development experience. 

Simbec-Orion’s MHRA Phase I accredited clinical site, which includes in-house bioanalytical capabilities, is based in Merthyr Tydfil, Wales, UK. 

In addition, it has offices in the USA, France and Hungary which can support single and multiple-site clinical studies in Europe and in the US. Simbec-Orion will provide an end-to-end, full-service clinical development solution including project management, medical and technical writing, medical monitoring and pharmacovigilance, as well as bioanalytical and statistical activities to support pharmacokinetic studies.

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