MHRA & REC 2 Approval for Phase 1 Clinical Trial

Oxford Cannabinoid Tech.Holdings

17 May 2023

 

17 May 2023

Oxford Cannabinoid Technologies Holdings plc

("OCTP" or the "Company")

MHRA and REC 2 approval of Phase I Clinical Trial Application

OCTP is pleased to announce that the Medicines and Healthcare Products Regulatory Agency ("MHRA") and the Wales Research Ethics Committee 2 ("REC 2") have approved the Company's combined Phase I clinical trial application for OCTP's lead drug candidate, OCT461201.

This Phase I first-in-human clinical trial is being conducted in the UK in healthy volunteers, with a single ascending dose protocol. The trial is being conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd ("Simbec-Orion") and 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.

Participant enrolment will begin immediately, and the trial is expected to be completed during Q3 2023. The trial is being funded entirely from OCTP's existing resources.

Growing global opportunity

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 is currently valued at US$1.61bn and is forecast to reach US$2.37bn by 2027.

Commenting on the MHRA and REC 2 approval, Clarissa Sowemimo-Coker, Chief Executive Officer of OCTP, said:

"We are absolutely thrilled to have passed this very significant milestone. Getting OCT461201 into the clinic so soon after our listing is a huge achievement and is a fitting testament to the hard work and dedication of both OCTP's talented team and our external partners, Aptuit (Verona) SRL, a subsidiary of Evotec SE, and Simbec-Orion. We are moving ever closer to achieving our core aim of improving the lives of patients living with debilitating pain, whilst also, ultimately, delivering value for shareholders.

"This is an important step for the Company and part of our broader strategy which currently incorporates four drug development programmes. We believe that our portfolio approach and extensive library of derivatives continue to provide numerous routes to commercialisation."

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 Clarissa Sowemimo-Coker (CEO) [phone] [e-mail]  Cairn Financial Advisers LLP Emily Staples Jo Turner [phone] [phone] Axis Capital Markets Limited Richard Hutchison Walbrook PR Limited Paul Vann Nick Rome [phone] [phone] [phone] [e-mail]

About Oxford Cannabinoid Technologies Holdings Plc:

Oxford Cannabinoid Technologies Holdings plc ("OCTP") is the holding company of Oxford Cannabinoid Technologies Ltd (together the "Group"), a pharmaceutical Group developing prescription cannabinoid medicines targeting the U$ multi-billion global pain market.

OCTP currently has a portfolio of four drug development programmes. Its lead compound, OCT461201, will initially target neuropathic and visceral pain (including irritable bowel syndrome ("IBS") and chemotherapy induced peripheral neuropathy ("CIPN")), with Phase I clinical trials, aimed at demonstrating safety and tolerability. Trial results are expected in Q3 2023.  The global market for CIPN alone is currently valued at US$1.61bn and is forecast to reach US$2.37bn by the year 2027.

OCTP's drug development pipeline, comprises both natural and synthetic compounds, and includes compounds targeting trigeminal neuralgia, a severe type of face pain, and cannabinoid derivatives targeting pain and potentially other therapeutic areas. Having established an exclusive license agreement with Canopy Growth Corporation for their entire pharmaceutical cannabinoid derivative library, OCTP now has a portfolio of almost 500 derivatives and intellectual property rights including 14 patent families and associated research data.

OCTP 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. OCTP's portfolio aims to balance risk, value and time to market, whilst ensuring market exclusivity around all its key activities.

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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