TIDMOCTP
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 +44 (0)20 3034 2820
Holdings plc
Dr John Lucas (CEO) john@oxcantech.com
Clarissa Sowemimo-Coker (COO) 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
identi ed 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 re ect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
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