Proactive Investors - Oxford Cannabinoid Technologies Holdings PLC (LON:OCTP) said it has submitted a Phase 1 trial application for its lead programme (OCT461201) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) and Wales Research Ethics Committee (REC), in what the company described as "milestone" as it moves from a pre-clinical stage to a clinical stage pharmaceutical company.
The combined clinical trials application, which was made in preparation for a review meeting to be held on 11 January 2023, follows the successful completion of the company’s pre-clinical work on OCT461201 under its £2.6mln contract research agreement with Evotec subsidiary Aptuit (Verona) SRL.
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).
OCTP said the Phase I first-in-human clinical trial 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 trial is due to commence in the first quarter of this year and expected to complete in the second quarter.
"We are very excited that the successful completion of the pre-clinical development of OCT461201 has resulted in such positive outcomes, especially as a potentially effective therapy for CIPN and IBS, supporting progress of our lead candidate to the next crucial phase of development - randomised, controlled clinical trials,” commented OCTP CEO Clarissa Sowemimo-Coker.
“This submission is a very significant milestone for both the company and its shareholders, as OCTP advances from a pre-clinical stage pharmaceutical company to a clinical stage pharmaceutical company. It moves us substantially closer to achieving our core aim of helping patients suffering from debilitating pain to feel better and have an improved quality of life, whilst also, ultimately, delivering value for shareholders."
The global market for CIPN was valued at US$1.61bn in 2020 and is forecast to reach US$2.37bn by the year 2027, the company noted.