REG - Oxford Cannabinoid - Submission of combined Clinical Trial Application

Oxford Cannabinoid Technologies HoldingsAnnouncement

05/01/2023 11:00

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RNS Number : 7985L  Oxford Cannabinoid Tech.Holdings  05 January 2023

 

OXFORD CANNABINOID TECHNOLOGIES HOLDINGS PLC

("OCTP" or the "Company")

 

Submission of combined Clinical Trial Application for Phase I Clinical Trials

 

Oxford Cannabinoid Technologies Holdings plc, the pharmaceutical company
developing prescription cannabinoid medicines targeting the US$ multi-billion
pain market, is pleased to announce that on 4 January 2023 it submitted a
combined clinical trials application for its lead programme, OCT461201, to the
UK Medicines & Healthcare products Regulatory Agency (MHRA) and Wales
Research Ethics Committee (REC) 2 (the "Submission") in preparation for a
review meeting to be held on 11 January 2023.

 

The Submission follows the successful completion of OCTP's extensive
pre-clinical work on OCT461201, under the Group's £2.6 million contract
research agreement with Aptuit (Verona) SRL, a subsidiary of Evotec SE.
OCT461201 is a selective cannabinoid receptor type 2 agonist which has shown
potential as an effective therapy for chemotherapy induced peripheral
neuropathy ("CIPN") as well as irritable bowel syndrome ("IBS"). The global
market for CIPN alone was valued at US$1.61bn in 2020 and is forecast to reach
US$2.37bn by the year 2027.

 

This Phase I first-in-human clinical trial, due to commence in Q1 2023, which
is being funded entirely from OCTP's existing resources, will be conducted in
the UK in healthy volunteers, with a single ascending dose. The trial aims to
demonstrate the safety and tolerability of OCT461201, whilst also providing
pivotal information on its pharmacokinetic profile, to confirm its value as a
potential drug. The clinical trial is anticipated to complete within Q2 2023.

 

Clarissa Sowemimo-Coker, Chief Executive Officer of OCTP, said:

 

"We are very excited that the successful completion of the pre-clinical
development of OCT461201 has resulted in such positive outcomes, especially as
a potentially effective therapy for CIPN and IBS, supporting progress of our
lead candidate to the next crucial phase of development - randomised,
controlled clinical trials. This submission is a very significant milestone
for both the Company and its shareholders, as OCTP advances from a
pre-clinical stage pharmaceutical company to a clinical stage pharmaceutical
company.  It moves us substantially closer to achieving our core aim of
helping patients suffering from debilitating pain to feel better and have an
improved quality of life, whilst also, ultimately, delivering value for
shareholders."

 

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

 Clarissa Sowemimo-Coker (CEO)                 clarissa@oxcantech.com

 Cairn Financial Advisers LLP

 Emily Staples                                 +44 (0)20 7213 0897

 Jo Turner                                     +44 (0) 20 7213 0885

 Axis Capital Markets Limited

 Kamran Hussain                                +44 (0)20 3026 0320

 Richard Hutchison

 finnCap Ltd

 Geoff Nash/Fergus Sullivan                    +44 (0) 20 7220 0500

 Nigel Birks (ECM)

 Walbrook PR Limited                           +44 (0)20 7933 8780

 Paul Vann/Nick Rome                           +44 (0)7768 807631

                                               oxcantech@walbrookpr.com

About Oxford Cannabinoid Technologies Holdings Plc:

Oxford Cannabinoid Technologies Holdings plc is the holding company of Oxford
Cannabinoid Technologies Ltd (together the "Group"), a pharmaceutical Group
developing prescription cannabinoid medicines for approval by key medicines
regulatory agencies worldwide and targeting the U$ multi-billion pain market.
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 OCTP in a solid oral dosage form. OCTP is conducting pre-clinical
testing and development with a clinical trial 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.

 

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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