The cannabinoid receptor, which has shown potential as an effective treatment for chemotherapy-induced peripheral neuropathy (CIPN) was approved for the phase 1 clinical study by the Medicines and Healthcare Products Regulatory Agency (MRHA) and The Wales Research Ethic Committee 2 (REC2) in June this year (2023).
No safety or tolerability concerns were exhibited with any dose tested. As a result, OCTP is satisfied that it is safe to proceed to the next stage of clinical development of its lead compound OCT461201.
The trial was conducted in the UK in healthy volunteers by Simbec Research Limited, part of Simbec-Orion Group Ltd, using a single ascending dose protocol. The final dose was administered on 20 September 2023, followed by a formal review of final clinical data on 2 October 2023. The trial's primary objective was to demonstrate the safety and tolerability of OCT461201, while also providing important information on its pharmacokinetic profile.
Clarissa Sowemimo-Coker, chief executive of OCTP, said: “I am delighted to announce the completion of our phase 1, single ascending dose study of our lead drug candidate, OCT461201. This is a significant milestone in OCTP’s journey as we cement our transition into a clinical-stage business.
Culmination of many years of hard work
“Today’s announcement represents the culmination of many years of hard work by our team, in particular from our chief scientific officer, Valentino Parravicini, and chief medical officer, Tim Corn, whose diligence and expertise have brought us to this point fewer than 30 months since flotation. We look forward to moving OCT461201 into its next phase of development.”
OCT461201 is a selective cannabinoid receptor type 2 agonist which the company says has not only shown potential as an effective therapy for CIPN but for irritable bowel syndrome (IBS) too. The global market for CIPN alone is currently valued at $1.61billion and is forecast to reach $2.37billion by 2027.
Dr Tim Corn, Chief Medical Officer of OCTP, said: “This announcement marks an important milestone in the clinical development of OCT461201. We are very pleased to have completed this stage in the development of our lead candidate. To have reached this point within this timeframe is a noteworthy achievement and one which we are well positioned to build upon.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (which forms part of domestic UK law under the European Union (Withdrawal) Act 2018).