REG - Oxford Cannabinoid - MSA and Work Order with Simbec Research

Oxford Cannabinoid Technologies HoldingsAnnouncement

20/07/2022 07:00

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RNS Number : 0398T  Oxford Cannabinoid Tech.Holdings  20 July 2022

OXFORD CANNABINOID TECHNOLOGIES HOLDINGS PLC

("OCTP" or the "Company")

 

Master Service Agreement and Work Order with Simbec Research Limited for Phase
1 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 19 July 2022, it entered into a
master service agreement and work order ("MSA") with Simbec Research Limited,
part of Simbec-Orion Group Ltd ("Simbec-Orion") for its first-in-human Phase 1
clinical trial for its lead compound, OCT461201, due to commence in Q1 2023.

 

This Phase 1 first-in-human clinical trial will be performed in the UK in
healthy volunteers, with a single ascending dose ("SAD"). The trial will be
aimed at demonstrating the safety and tolerability of the drug product, while
providing pivotal information on the pharmacokinetic profile of OCT461201 to
confirm its value as a potential drug. The clinical trial is anticipated to
commence in Q1 2023, following regulatory submission to the UK Medicines &
Healthcare products Regulatory Agency (MHRA), with interim results expected by
the end of March 2023 and the full report expected in Q2 2023.

 

Simbec-Orion is an award winning, full-service clinical research organisation
("CRO") with over 45 years' specialist expertise in clinical pharmacology and
lab expertise and over 25 years' clinical development experience. With a
combination of pharmacology first-in-man and patient, oncology and rare
disease expertise in highly complex indications, the directors of OCTP are
confident that Simbec-Orion is the right partner to help OCTP meet this
significant milestone. OCTP's lead compound, 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. The global market for CIPN alone was valued at
US$1.61bn in 2020 and is forecasted to reach US$2.37bn by the year 2027.

 

Simbec-Orion's MHRA Phase I accredited clinical site, which includes in-house
bioanalytical capabilities, is based in Merthyr Tydfil, Wales, UK. In
addition, it has offices in the USA, France and Hungary which can support
single and multiple-site clinical studies in Europe and in the US.
Simbec-Orion will provide an end-to-end, full-service clinical development
solution including project management, medical and technical writing, medical
monitoring and pharmacovigilance, as well as bioanalytical and statistical
activities to support pharmacokinetic studies.

 

Under the terms of the MSA Simbec-Orion shall provide services to OCTP on a
call-off basis and as specified in individually agreed work orders. Work
orders will specify, inter alia, scope of work to be performed as well as
milestones to be achieved and fees payable. OCTP owns all data created and
intellectual property rights generated under the MSA and any work order and
the MSA includes standard confidentiality provisions. Both OCTP and
Simbec-Orion give the standard indemnities, representations and warranties
expected from agreements of this nature and OCTP is to comply with the ABPI
guidelines for compensation of trial subjects. Quality agreements and transfer
of regulatory obligations under a work order are each incorporated by
reference. The MSA requires a specific data processing agreement under each
work order for the processing of personal data of clinical trial subjects. The
MSA also includes standard confidentiality provisions for trial site contract
management, insurance and audit as well as a right to terminate the MSA and
individual work orders for convenience for OCTP.

 

Dr John Lucas, Chief Executive Officer of OCTP, said: "We are very excited to
partner with Simbec-Orion as we progress our drug candidates to the next
crucial phase of their development - randomised, controlled clinical trials.
This work with Simbec-Orion helps the Company deliver the targets we set out
in our prospectus and meets the quality standards we set to safeguard
patients.

 

"This is an important step along the development path for OCT461201, as we
advance into clinical trials in healthy volunteers, getting us closer to the
aim of providing a much-needed safe and effective pain treatment for patients
whilst also, ultimately, generating 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

 Dr John Lucas (CEO)                           john@oxcantech.com

 Clarissa Sowemimo-Coker (COO)                 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

 Walbrook PR Limited                           +44 (0)20 7933 8780

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

                                               oxcantech@walbrookpr.com

 Harbor Access LLC

 Richard Leighton/Jonathan Paterson            +1 (475) 455 9403

                                               Richard.Leighton@HarborAccessllc.com

About Oxford Cannabinoid Technologies Holdings plc:

Oxford Cannabinoid Technologies Holdings plc ("OCTP") is the holding company
of Oxford Cannabinoid Technologies Ltd ("OCT") (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 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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