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OCT461201, the Group’s lead compound, is a highly potent and selective CB2 agonist and is being developed by OCT as a solid oral dosage form. The compound was in-licensed in September 2019, creating a shorter development time to value inflection compared to drug candidates from the Group’s cannabinoid derivative library. Through its agreements with external CROs, the Group is continuing the pre-clinical testing and development of OCT461201, which will be followed by Phase 1 clinical trials, for IBS and post herpetic neuralgia as primary indications and an undisclosed neuropathic pain condition as a secondary indication.

OCT461201 has a good in vitro safety profile, with negative results in terms of genotoxicity and cardiotoxic liabilities, as well as in a panel of potential off target liabilities. The compound has also demonstrated excellent in vivo pharmacokinetic characteristics in terms of maximum blood concentrations and half-life. A patent covering the compound is in force. A full pre-clinical in vivo translational, pharmacological and toxicological programme will enable transition to clinical trials, while confirming safety and efficacy in the Group’s target indications. The Group is aiming to enter clinical trials with OCT461201 in Q3 2022, and anticipates being ready to enter Phase 2 clinical trials in Q2 2023.

Through its partnering model the Group is currently developing a commercially viable method of synthesising the compound on a large- scale basis. It is anticipated by the Directors that the clinical drug development path will allow the Group to leverage the knowledge acquired by existing and newly generated efficacy, pharmacological and safety data to expand across multiple indications (beyond the three currently envisaged) and progress OCT461201 in parallel clinical studies. The Group aims to expedite OCT461201 to smaller, faster and less expensive clinical trials focussing primarily on orphan diseases, particularly neuropathic pain conditions, while considering out-licensing for other indications (e.g. non-pain indications).