Oxford Cannabinoid Tech.Holdings Submission of combined Clinical Trial Application (7985L)
January 05 2023 - 4:46AM
UK Regulatory
TIDMOCTP
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 GBP2.6
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 +44 (0)20 3034 2820
Holdings plc clarissa@oxcantech.com
Clarissa Sowemimo-Coker (CEO)
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
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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