Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTCQB:OCTHF) said it was making good progress on its two lead cannabinoid medicines in pre-clinical development.
For OCT461201, which is being tested for both neuropathic and visceral pain, there has been “very encouraging” data, with successful reduction of pain in a model chemotherapy-induced peripheral neuropathy (CIPN).
As a result, the company has decided to focus its strategy in neuropathic pain away from post-herpetic neuralgia (PHN) and towards a clinical development programme aimed to benefit patients with small fibre neuropathies, such as cancer patients suffering from nerve damage caused by treatment with chemotherapy, and potentially also for patients suffering from diabetic neuropathy.
There are currently no approved therapies for CIPN, the company said, with many sufferers being given a mixture off-label use of gabapentinoids and antidepressants, which not only can still leave cancer patients in pain but are also are associated with serious side effects.
OCT said this large unmet medical need in CIPN is estimated to have a global market valued at US$1.61bn in 2020 and forecast to reach US$2.37bn by the year 2027, with expansion to other small fibre neuropathies potentially growing the total addressable market to over US$7bn, the directors believe.
In addition to CIPN, the company said it will continue to develop OCT461201 for visceral pain in patients suffering from irritable bowel syndrome.
Chief scientific officer Valentino Parravicini said: “Our research ethos is to develop breakthrough therapies for debilitating pain conditions with significant unmet medical needs. Although we are replacing PHN with CIPN for OCT461201, we are making good progress in line with the strategy stated in our IPO prospectus and on our revised focus to benefit patients with small fibre neuropathies, such as cancer patients suffering from nerve damage caused by treatment with chemotherapy.”
The second programme, OCT130401, is a drug-device combination delivering phytocannabinoids (pCBs) to patients suffering from trigeminal neuralgia (TN) with a pressurised metered-dose inhaler. The company said it currently intends to undertake phase one clinical trials in the fourth quarter of 2022 in healthy volunteers in Australia, where there is local experience in performing clinical trials with pCBs.
The company said it is currently executing due diligence on potential clinical research partners and has entered into a five-year master service agreement with Texas-based Benuvia Manufacturing, with the intention of agreeing the manufacture of the drug-device combination for use in phase 1 clinical trials, in compliance with current good manufacturing practice (cGMP).
TN, which is characterised by sudden, severe facial pain and is difficult to treat with conventional systemic medicines, affects an estimated 60,000-95,000 in the UK, while cases are on the rise in the US, with between approximately 10,000 and 15,000 new cases diagnosed in the US alone each.