Oxford Cannabinoid Technologies Holdings Plc announced that the Medicines and Healthcare Products Regulatory Agency ("MHRA") and the Wales Research Ethics Committee 2 ("REC 2") have approved the Company's combined Phase I clinical trial application for OCTP's lead drug candidate, OCT461201. This Phase I first-in-human clinical trial is being conducted in the UK in healthy volunteers, with a single ascending dose protocol. The trial is being conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd. ("Simbec-Orion") and 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.

Participants enrolment will begin immediately, and the trial is expected to be completed during Third Quarter 2023. The trial is being funded entirely from OCTP's existing resources. Growing global opportunity 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 is currently valued at USD 1.61 billion and is forecast to reach USD 2.37 billion by 2027.