Updates on Lead Programme 1 (OCT461201) and Programme 2 (OCT130401) - Trigeminal Neuralgia Clinical Trial
Programme 1 - OCT461201
OCT461201 is being tested in multiple translational models of both neuropathic and visceral pain.
The conclusive analysis of recent pre-clinical data has shown that OCT461201 is well positioned for small fibre neuropathies, as it successfully reduced pain in a model of chemotherapy-induced peripheral neuropathy (CIPN). Recent results from other neuropathic pain models suggest OCT461201 may not be effective in post-herpetic neuralgia (PHN). The Company is therefore replacing PHN with CIPN as an indication for OCT461201.
In response to these very encouraging data in CIPN, the Company's strategy in neuropathic pain, is to focus on 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, patients suffering from diabetic neuropathy.
There is an urgent need for new therapies to treat CIPN as there are currently no approved therapies for this condition. The current standard of care is the off-label use of gabapentinoids (gabapentin and pregabalin) and antidepressants (e.g. duloxetine), drugs associated with serious side effects. Furthermore, in some cases their overall clinical effectiveness is inadequate, leaving cancer patients in pain, with a reduced quality of life and the prospect of having to change or stop their chemotherapy altogether.
The large unmet medical need in patients suffering from 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, which, in the view of the Directors, could grow to over US$7bn once combined with other small fibre neuropathies.
In addition to CIPN, the Company will continue to develop OCT461201 for visceral pain in patients suffering from irritable bowel syndrome (IBS).
Programme 2 - OCT130401 - Trigeminal Neuralgia Clinical Trial
OCT130401 is a drug-device combination delivering phytocannabinoids (pCBs) to patients suffering from trigeminal neuralgia (TN) with a pressurised metered-dose inhaler (pMDI). TN causes debilitating and excruciating pain, has a fast and unexpected onset and is difficult to treat with conventional systemic medicines.
OCTP intends to undertake its phase one clinical trials for OCT130401 (currently anticipated in Q4 2022) in healthy volunteers in Australia, in order to benefit from the experience of local Human Research Ethical Committees (HREC), medical institutions, and clinical research organisations (CROs) in supporting and performing clinical trials with pCBs. The Company is currently executing its due diligence process of selecting a partner CRO to expedite the route to first in human trials while ensuring quality and patients' safeguarding.
In addition, OCTP has entered into a five-year Master Service Agreement with Benuvia Manufacturing Inc. (Benuvia). The Company anticipates that it will shortly agree a Statement of Work with Benuvia for the manufacture of the drug-device combination for use in phase 1 clinical trials. The manufacture will be in compliance with current good manufacturing practice (cGMP).
TN is on the rise with between approximately 10,000 and 15,000 new cases in the United States diagnosed each year. The Directors estimate that in 2021 there were between 60,000 and 95,000 people living with the condition in the UK.
Commenting on recent developments, 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".