The science behind OCT

In this op-ed we look back on what the business has accomplished since we published our first op-ed, almost exactly a year ago, by diving into the science behind our programmes. Since September 2023, we’ve completed our first clinical trial, and are now well positioned to commence our second one; we’ve appointed a Chief Medical Officer which reflects our strategic transition from a pre-clinical to a clinical stage biopharma business; we became founding members of the Cannabinoid Research & Development Group ( CRDG UK ) launching our inaugural report in July; and, last and by no means least, we’ve decided to become a privately held business once more, better placed to onboard external capital in order to support further research, growth and journey into the future.

So, after an action-packed 12 months, we’re taking this opportunity to revisit some of the science behind our work, and recap on why we do what we do and, crucially, how we do it differently from others in the sector.

There are two core drivers for our work. The first is our firm belief in the therapeutic potential of cannabinoids and the untapped potential and possibility to be unlocked by targeting the endocannabinoid system in the human body. The second is driven by the global concern about using opioids to treat pain, addiction to which results in hundreds of thousands of needless deaths each year. While opioids have a role to play in some situations, at OCT we’re developing non-addictive pain medications which will reduce reliance on them.

Without companies like OCT and the clinical advancements we’re pioneering, the sad fact is that clinicians currently have very few choices when it comes to prescribing licensed medicines for treating chronic pain, leading doctors to continue prescribing opioids in spite of the known dangers of harm and addiction.

We believe that targeting the endocannabinoid system presents a worthy, indeed compelling, solution to this opioid crisis, with thousands of chronic pain sufferers already using cannabis to alleviate their symptoms every day. But it is equally true that many doctors in general practice, continue to be put off by the fact that most evidence for cannabinoids treating pain effectively is anecdotal and there remains a paucity of extensive and robust scientific evidence. We recognise this picture all too well, which is why we’re working so hard on scientific studies to provide the evidence that cannabinoids can be effective in treating chronic pain. We completed our Phase I single-ascending-dose clinical trial for Programme 1 (OCT461201) last October, with no safety or tolerability concerns. While we recognise that a Phase I trial is, as the name suggests, still only an early step in the process, the signs are promising and we look forward to continuing to advance this programme through the clinic to bring much needed help to those living with neuropathic pain.

So what makes our products distinct and different from medical cannabis?

The medicines we’re developing at OCT are new chemical entities (NCEs) that have been created by medicinal chemists and only contain synthesised cannabinoids, which helps to ensure uniformity and certainty in dosing and therapeutic effects. Medical cannabis products, on the other hand, are derived from the whole cannabis plant or its extracts and contain a mix of cannabinoids, which can vary widely depending on the strain and preparation method. The composition is less standardised, and the proportionate concentrations of THC and CBD can differ widely between products. On top of this, regulations for medical cannabis can vary widely between jurisdictions, and these products are not required to go through the same rigorous testing and approvals processes that pharmaceuticals do. Currently, the only requirement on a company producing unlicensed medical cannabis is to demonstrate manufacturing standards on how the product is made, not the effect it can have on the people who take it. This variation can lead to uncertainty for physicians and patients. All this means that the Medicines and Healthcare products Regulatory Authority (MHRA) sees what we do as wholly separate from the approach of non-biopharma/non-pharmaceutical medical cannabis companies.

Currently, there are just three licensed cannabinoid medicines in the UK, each licensed to treat only a very specific set of conditions, like treatment-resistant epilepsy in children. Beyond these particular conditions, all other medical cannabis in the UK is unlicensed in the eyes of the MHRA. This is why we’re pursuing a pharmaceutical approach, because we recognise that this truly is the best and safest long-term solution to the serious and chronic conditions faced by people and the one most likely to instil confidence among patients and, therefore, promote adoption. Naturally, all of this takes time. But we’re confident that, if successful, the resulting treatments will provide real solutions for patients living with debilitating conditions.

Now we’ve touched on some of the reasons why we take a pharmaceutical approach here at OCT, it’s time to consider how we’re actually putting this into practice, namely, our programmes.

Programme 1 here at OCT is targeting peripheral neuropathies such as chemotherapy-induced peripheral neuropathy (CIPN), a challenging complication arising from treatment with many commonly used anti-cancer agents. For those living with this debilitating condition, CIPN manifests itself as pain, numbness and tingling in the extremities, sometimes necessitating a reduction in the dosage of chemotherapy or even for the course of treatment to be stopped before its intended completion. Either of these outcomes can have significant adverse implications for the efficacy of oncological treatment and patient survival rates.

Though many will not have heard of CIPN before, it is, sadly, much more widespread than is often understood, affecting around 60% of people undergoing chemotherapy after 3 months. It can be, besides painful, also regressive, and enduring, with 30% of sufferers still experiencing CIPN a year or more after completing chemotherapy treatment.

At OCT, we don’t wish to see anyone experiencing these years of debilitating and degenerative pain, especially as a result of treatment for cancer. That’s why we’re working so hard to bring a treatment through the clinic and to patients, since there are currently very limited treatments for CIPN on the market. Although we’re not yet in touching distance of the finish line, our Phase I single-ascending-dose clinical trial for OCT461201 was completed successfully last year and we’re now satisfied that it is safe to move the drug into the next stage of its clinical development. Our work goes on and we look forward to providing regular updates on the next stages in this important research programme.

CIPN is not the only condition, however, that we’re targeting here at OCT: we anticipate enormous impact and value from our strategy of pursuing a diversified pipeline of drug candidates. While Programme 1 focuses on peripheral neuropathies, our second programme (OCT130401) targets Trigeminal Neuralgia (TN).

TN is a debilitating neurological disorder that affects the trigeminal nerve, a cranial nerve responsible for sensation in the face which is vital for everyday motor functions such as biting and chewing. TN is defined by NHS England as a sudden, severe facial pain akin to experiencing an electric shock in the jaw, teeth or gums, and it can be triggered by the smallest of inputs such as speaking, eating, a light touch or, even, a gentle breeze.

While TN is a rare disease, there are still 150,000 diagnoses worldwide every year, and it is thought to affect women in particular, with its onset typically manifesting itself between the ages of 50 and 60.

At the moment, many cases of TN are initially treated with a small dose of an anti-epileptic drug, such as carbamazepine, which can provide significant pain relief. However, up to 10% of patients will not respond to these anti-epileptic drugs. Here at OCT, we believe no one deserves to live with the constant anxiety of the sudden onset of severe pain and in the knowledge that there are, currently, limited treatment options on offer. That’s why we’re busy researching a solution designed to alleviate this pain. Our OCT130401 (Programme 2) is in development and is due to be trialled as a treatment for TN. It has already completed its pre-clinical development and is ready to commence its Phase I clinical trials. We hope that, through our plan to deliver OCT130401 treatments via an inhaler, we will be able to bring about a faster onset of pain relief when compared to other systemic routes such as tablets.

In addition to our Programmes 1 and 2, we’re already undertaking prelimary research on Programme 3 which is focused on a range of potential neuropathic pain indications, as well as Programme 4, which is aimed at an oncology target. We’ll be saying more about our progress in relation to these research programmes in due course.

All of the conditions that we are targeting at OCT, and have surveyed in this article, are in areas of key clinical need where patients either do not respond to existing treatments, or where there simply are not effective medicines currently licensed for their condition. Finding treatments for these uncommon diseases gives us market exclusivity, reduces development costs, and opens up the possibility of us receiving incentives from the regulatory authorities for our work. But that’s not the primary reason we do it.

We do what we do because we’re truly passionate about harnessing the therapeutic power of cannabinoids to help people living with debilitating conditions. We’re also immensely proud of the progress we’ve made over the past 12 months as we advance along our journey to deliver material improvements in people’s lives.

We look forward to telling you more about our progress and clinical experiences in the months to come.