REG - Oxford Cannabinoid - Updates on Lead Programme 1 and Programme 2

Oxford Cannabinoid Technologies HoldingsAnnouncement

31/03/2022 07:00

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RNS Number : 6806G  Oxford Cannabinoid Tech.Holdings  31 March 2022

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:

 Oxford Cannabinoid Technologies Holdings plc  +44 (0)20 3034 2820

 Dr John Lucas (CEO)

 Clarissa Sowemimo-Coker (COO)                 john@oxcantech.com

                                               clarissa@oxcantech.com
 Cairn Financial Advisers

 Emily Staples                                 +44 (0)20 7213 0897

 Jo Turner                                     +44 (0) 20 7213 0885

 Walbrook PR Limited                           +44 (0)20 7933 8780

 Paul Vann                                     +44 (0)7768 807631

 Nicholas Johnson                              oxcantech@walbrookpr.com

 Harbor Access LLC (US/OTCB enquiries)

 Jonathan Paterson                             +1 (203) 862 0492

 Richard Leighton                              Richard.Leighton@harboraccessllc.com

 

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.

 

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