A pharmaceutical approach to cannabinoids
People living with debilitating conditions need the reassurance that only clinically-proven, safe and effective treatments that have been approved by drug regulatory agencies can provide.
At Oxford Cannabinoid Technologies Holdings Plc, we are committed to delivering breakthrough therapies for debilitating conditions with a significant unmet medical need, aligning our strategy to meet the needs of people in the journey through pre-clinical research, clinical trials, and high-quality patient care.
Today, we examine why, unlike medical cannabis companies, all our drug candidates are being developed through a regulatory pathway, which subjects them to rigorous scientific scrutiny, and how this leads to better outcomes for patients and doctors.
Millions of people are living with chronic pain that is either unresolved by or is resistant to current treatments (opioids, or anti-inflammatory, anti-convulsant and anti-depressant drugs). Many of these treatments have severe side effects or, worse, can lead to addiction. It is for this reason that, at OCT, we are developing treatments from our library of over 500 proprietary cannabinoid derivatives designed precisely to target specific pain conditions such as chemotherapy-induced peripheral neuralgia (CIPN), irritable bowel syndrome (IBS) and Trigeminal Neuralgia (TN).
In order to develop new, licensed, and effective treatments, we work alongside regulatory agencies at every step of our drug development process. Our goal is to create standardised, controlled, and well-characterised medications that can be prescribed by doctors for specific medical conditions.
Pharmaceuticals developed through a regulatory approach are designed to have precise and consistent cannabinoid compositions. Our medicines typically contain synthesized cannabinoids, which helps to ensure uniformity in dosing and therapeutic effects. In contrast, medical cannabis products are derived from the whole cannabis plant or its extracts. They contain a mix of cannabinoids, which can vary widely depending on the strain and preparation method. The composition is less standardised, and the relative concentrations of THC and CBD can differ significantly between products. Regulations for medical cannabis can vary widely, and these products are unlikely to go through the same rigorous testing and approval processes as pharmaceuticals. This variation can lead to uncertainty for physicians and patients.
In line with our pharmaceutical strategy, in May this year, we were pleased to announce that the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Wales Research Ethics Committee 2 (REC 2) had approved our combined single-ascending-dose Phase I clinical trial application for our lead drug candidate, OCT461201, which targets a first-in-class treatment for CIPN. Phase I trials are proceeding satisfactorily and we expect that results will be reported in Q3 2023. Assuming successful completion of this Phase I trial, we will then be able to move forward the clinical trial process into a multiple-ascending-dose study, Phase II trials, and beyond.