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Clinical trial application submitted to MHRA for cannabinoid medicine

Home » Clinical trial application submitted to MHRA for cannabinoid medicine

Oxford Cannabinoid Technologies Holdings (OCTP) has 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).

OCT461201 is a selective cannabinoid receptor type 2 agonist which OCTP is investigating for chemotherapy induced peripheral neuropathy (CIPN) as well as irritable bowel syndrome (IBS).

The Submission follows the successful completion of the company’s pre-clinical work on OCT461201, under the Group’s £2.6 million contract research agreement with Aptuit (Verona) SRL, a subsidiary of Evotec SE. 

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Chief Executive Officer of OCTP, Clarissa Sowemimo-Coker, said: “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. 

“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.”

This Phase I first-in-human clinical trial, due to commence in Q1 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 Q2 2023.

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