Oxford Cann Regulatory News (OCTP)

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.

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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 identied 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 reect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.