Oxford Cannabinoid Technologies Holdings plc announced that on 4 January 2023 it submitted a combined clinical trials application for its lead programme, OCT461201, to the UK Medicines & Healthcare products Regulatory Agency (MHRA) and Wales Research Ethics Committee (REC) 2 (the Submission) in preparation for a review meeting to be held on 11 January 2023. The Submission follows the successful completion of OCTP's extensive pre-clinical work on OCT461201, under the Group's £2.6 million contract research agreement with Aptuit (Verona) SRL, a subsidiary of Evotec SE. OCT461201 is a selective cannabinoid receptor type 2 agonist which has shown potential as an effective therapy for chemotherapy induced peripheral neuropathy ("CIPN") as well as irritable bowel syndrome ("IBS").

The global market for CIPN alone was valued at USD 1.61 billion in 2020 and is forecast to reach USD 2.37 billion by the year 2027. This Phase I first-in-human clinical trial, due to commence in first quarter 2023, which is being funded entirely from OCTP's existing resources, will be conducted in the UK in healthy volunteers, with a single ascending dose. The trial aims to demonstrate the safety and tolerability of OCT461201, whilst also providing pivotal information on its pharmacokinetic profile, to confirm its value as a potential drug.

The clinical trial is anticipated to complete within second quarter 2023.