How our regulatory approach differs from medical cannabis
At OCT, we are often asked how our approach differs from that of medical cannabis companies.
In the UK, the medicines regulatory authority (MHRA) sees what we do as separate to the approach of non-biotech/non-pharmaceutical medical cannabis companies. Whilst these medical cannabis companies are selling unlicensed products, we, as a biotech company, are taking the route of licensed medicines, a route similar to any of the non-cannabinoid medicines that you might be prescribed by your doctor like a course of antibiotics. Currently there are only 3 licensed cannabinoid medicines in the UK, all available for very specific conditions like treatment-resistant epilepsy in children. Outside these very specific conditions, all other medical cannabis in the UK is unlicensed in the eyes of the MHRA.
We have taken the decision to harness the power of cannabis into the production of licensed products for three important reasons: ensuring that the medicine acts in exactly the same way everytime it is taken; giving doctors the confidence to prescribe treatments to patients and; offering patent protections and market exclusivity to assure our investors.
At OCT, we can take properties of the cannabis flower and chemically add to or change them or completely synthetically reproduce them to ensure that, when the medicine is administered, it has the benefit of acting in the body in a specific way and at a specific point. This approach ensures that the medicine acts in exactly the same way everytime it is taken. Due to the limits on their ability to alter the properties of the cannabis flower itself, medical cannabis companies cannot do this. Our lead drug candidate, OCT461201, which is aiming to reduce pain associated with chemotherapy-induced peripheral neuropathy (CIPN) and irritable bowel syndrome (IBS), exploits the same receptor targeted by some natural cannabis extracts. It is chemically modified to ensure that it effectively and exclusively binds to the key receptor (CB2) in the nerves and immune cells that contribute to controlling the pain response, and it will do this in the same way every time a patient takes it. Through the creation of these new chemical entities, which are chemically synthesized to behave like a cannabinoid, we are hoping to deliver a treatment to patients which effectively and specifically targets their conditions, which, we hope, will result in improved patient outcomes.
At OCT, we know that there is a reluctance from doctors to prescribe unlicensed medicines because there is no requirement for suppliers of these medicines to complete the robust clinical trials that are mandated for licensed medicines. NHS England says that unlicensed cannabis medicines can only be prescribed by speclialist hospital doctors and, then, only when they believe it to be in their patients’ best interests, and when other treatment options have not worked or have not proved to be suitable. We understand that medical professionals need the evidence when they are prescribing any medicine that it has been thoroughly tested and shown to be of benefit, and a licensed medicine can provide this reassurance. Currently, the only requirement on a company producing unlicensed medical cannabis is to demonstrate manufacturing standards on how the product is made, not theeffect it can have on people who take it. At OCT, through pursuing a licensed route for our drug candidates, we are hoping to provide a solution to this challenge by creating treatments which have received approval from regulatory bodies such as the MHRA and FDA. In this way, we aim to provide clinicians with the evidence they need to prescribe them to patients with confidence, safe in the knowledge that our treatments have undergone rigorous clinical trials.
At OCT, we recognise that, for our investors, our licensed route ensures that, in addition to patent protections, our medicines will also achieve market exclusivity and provide access to orphan disease indications.
For our team at OCT, we belive that the licensed route to market is the best long-term solution to the serious and chronic illnesses faced by people who could benefit from cannabinoid medicines. For these people, who live with such debilitating conditions, it is important to know that the medicine they take has been rigorously tested and shown to have a benefit in treating the condition that is affecting them. Pursuing this regulatory approach to creating licensed medicines does mean that it takes time; we are confident, however, that, if we are successful, the resulting treatments will provide first-in-class solutions for patients living with debilitating conditions which have transformative potential.
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