OCTP.L Regulatory News (OCTP)

31 March 2022

Oxford Cannabinoid Technologies Holdings plc

("OCTP", or the "Company")

Updates on Lead Programme 1 (OCT461201)

and Programme 2 (OCT130401) - Trigeminal Neuralgia Clinical Trial

Oxford Cannabinoid Technologies Holdings plc (LSE: OCTP, OTCQB: OCTHF), the pharmaceutical company developing prescription cannabinoid medicines targeting the US$ multi-billion pain market is pleased to present an update on the development of its two lead compounds.

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".

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (which forms part of domestic UK law pursuant to the European Union (Withdrawal) Act 2018).

The Directors of the Company accept responsibility for the content of this announcement.

Enquiries:

About Oxford Cannabinoid Technologies Holdings Plc:

Oxford Cannabinoid Technologies Holdings plc is the holding company of Oxford Cannabinoid Technologies Ltd, a pharmaceutical company developing prescription cannabinoid medicines for approval by key medicines regulatory agencies worldwide and targeting the U$ multi-billion pain market (together the "Group"). Cannabinoids are compounds found in the cannabis plant that have been shown to have a range of therapeutic effects on the body, including pain relief. The Group has a clearly defined path to commercialisation, revenues and growth. The Group is developing drug candidates through clinical trials to gain regulatory approval (FDA/MHRA/EMA) that will enable medical professionals to prescribe them with confidence.

The Group's portfolio aims to balance risk, value and time to market, whilst ensuring market exclusivity around all its key activities. The Group's lead compound, OCT461201, is a highly potent and selective CB2 agonist and is being developed by OCT in a solid oral dosage form. OCT is conducting pre-clinical testing and development with clinical trials scheduled for Q1 2023. The Group's product pipeline also uses a balanced drug product strategy that employs both natural and synthetic compounds for the treatment of rare diseases and includes chemically modified phytocannabinoids with improved drug-like characteristics and a proprietary library of cannabinoids.

OCTP operates a partnership model with external academic and commercial partners.

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should" ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', "expect", ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.