Cannabinoid receptor given approval for trial after benefits revealed for chemo and IBS patients

08-Jun-2023 - Last updated on 08-Jun-2023 at 09:10 GMT

A cannabinoid receptor, that has shown potential as an effective treatment for chemotherapy induced peripheral neuropathy (CIPN) has been given approval for a phase 1 clinical trial by the Medicines and Healthcare Products Regulatory Agency (MRHA) and The Wales Research Ethics Committee 2 (REC 2).

Oxford Cannabinoid Technologies Holdings plc (OCTP) will now conduct the first-in-human trial for its lead candidate, OCT461201.

It is being conducted in the UK in healthy volunteers, with a single ascending dose protocol. The trial is being run by Simbec Research Limited, part of Simbec-Orion Group Ltd and OCTP says it 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.

Participant enrolment began immediately, and the trial is expected to be completed during the third quarter of this year (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 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.

Clarissa Sowemimo-Coker, chief executive officer of OCTP, said: “We are absolutely thrilled to have passed this very significant milestone. Getting OCT461201 into the clinic so soon after our listing is a huge achievement and is a fitting testament to the hard work and dedication of both OCTP’s talented team and our external partners, Aptuit (Verona) SRL, a subsidiary of Evotec SE, and Simbec-Orion.

“We are moving ever closer to achieving our core aim of improving the lives of patients living with debilitating pain, whilst also, ultimately, delivering value for shareholders.

“This is an important step for the Company and part of our broader strategy which currently incorporates four drug development programmes. We believe that our portfolio approach and extensive library of derivatives continue to provide numerous routes to commercialisation.”

CB (1) receptors are present in very high levels in several brain regions and more widespread in lower amounts. These receptors mediate many of the psychoactive effects of cannabinoids. CB (2) receptors have a more restricted distribution, being found in a number of immune cells and in a few neurones.

One study provides evidence to suggest that cannabis use may decrease healthcare utilization and costs among hospitalized patients with IBS. The reseasrchers said these findings were likely attributable to the effects of cannabis’ active compound, THC, on gastrointestinal motility and colonic compliance.

They said: "The role of cannabis in the treatment for IBS has potential for significant impact at the individual and population level given the burden of IBS on individual quality of life and healthcare expenditures."

Another study revealed that in selected patients, the cannabinoids tested in these trials may be useful as mood enhancing adjuvants for controlling chemotherapy related sickness.