Oxford Cannabinoid Technologies has signed a deal with drug development firm Evotec as it moves towards Phase 1 clinical trials in humans.
The UK-based pharmaceutical company, which is focused on developing cannabinoid-based prescription medicines, has entered into a service agreement with Aptuit (Verona) SRL, a subsidiary of Evotec, a fully integrated drug discovery and development company.
This agreement will use Evotec’s technology platform to expedite the development of OCT’s lead compound, OCT461201, a selective cannabinoid receptor type 2 agonist, towards Phase 1 clinical trials.
This Phase 1 clinical trial will be aimed at demonstrating the safety and tolerability of the drug product.
OCT461201 will enter Evotec’s INDiGO programme, an integrated drug development process for accelerating early drug candidates to clinical trial stage.
The INDiGO programme, which has an anticipated duration of approximately 12 months, seeks to clear OCT461201 for its first in-human clinical studies.
It will provide comprehensive manufacturing, safety, and toxicology packages for regulatory submission to the UK Medicines & Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).
Evotec will also manufacture and formulate the OCT461201 drug product for use in clinical studies.
The Evotec INDiGO programme has the potential to quicken the pace of sector-wide innovation and brings closer the day when OCT may be able to create a suite of new drugs that will be able to treat chronic pain and improve patients’ lives.
Dr John Lucas, chief executive officer of OCT, said: “We are very excited to enter this partnership with Evotec and progress our drugs candidate pipeline to the next stage. The directors are focused on delivering on the development timeline we set out in our prospectus, and signing this agreement keeps the company firmly on that path.
“Evotec was selected as our drug development partner based on its professionalism and track record. Evotec’s broad range of integrated capabilities spanning the R&D process will power our cannabinoid discovery engine, limiting the risk of delays and enabling successful progression.
“Specifically, this service agreement will help accelerate our lead compound, OCT461201, towards first in-human clinical trials and, ultimately to patients, to provide a much-needed safe and effective pain treatment.”
Based in Hamburg, Evotec SE has sites in Germany, Austria, France, Italy, the UK, and the US, and Evotec states that it has successfully completed in excess of 50 INDiGO projects.
Dr Craig Johnstone, chief operating officer of Evotec SE, added: “We are very glad to enter this agreement with OCT to support the development of their lead compound OCT461201.
“Our integrated INDiGO offering is designed to de-risk projects during pre-clinical development by taking an integrated approach, solving problems and managing all process steps under one roof. Within the more than 50 INDiGO projects completed successfully, we have averaged a timeline of just 46 weeks by prioritising science, quality, and interdisciplinary coordination. We look forward to working with the team at OCTP as OCT461201 proceeds towards the clinic.”
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