Phase I Clinical Trial Results

Oxford Cannabinoid Tech.Holdings

10 October 2023

 

Oxford Cannabinoid Technologies Holdings plc

("OCTP" or the "Company")

Phase I Clinical Trial Results for Lead Drug Candidate OCT461201

Oxford Cannabinoid Technologies Holdings plc (LSE: OCTP), the pharmaceutical company developing prescription cannabinoid medicines, is pleased to announce that dosing of all the cohorts of the Phase I, single ascending dose study for OCT461201 has been successfully completed. No safety or tolerability concerns were exhibited with any dose tested. As a result, OCTP is satisfied that it is safe to proceed to the next stage of clinical development of its lead compound OCT461201.

The trial was conducted in the UK in healthy volunteers by Simbec Research Limited, part of Simbec-Orion Group Ltd, using a single ascending dose protocol. The final dose was administered on 20 September 2023, followed by formal review of final clinical data on 2 October 2023. The trial's primary objective was to demonstrate the safety and tolerability of OCT461201, whilst also providing important information on its pharmacokinetic profile.

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

"I am delighted to announce the completion of our Phase I, single ascending dose study of our lead drug candidate, OCT461201. This is a significant milestone in OCTP's journey as we cement our transition into a clinical-stage business. Today's announcement represents the culmination of many years of hard work by our team, in particular from our Chief Scientific Officer, Dr Valentino Parravicini, and Chief Medical Officer, Dr Tim Corn, whose diligence and expertise have brought us to this point fewer than 30 months since flotation. We look forward to moving OCT461201 into the next phases of its development".

Dr Tim Corn, Chief Medical Officer of OCTP, said:

"This announcement marks an important milestone in the clinical development of OCT461201. We are very pleased to have completed this stage in the development of our lead candidate. To have reached this point within this timeframe is a noteworthy achievement and one which we are well positioned to build upon."

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	[phone]
Clarissa Sowemimo-Coker (CEO)	[e-mail]
Cairn Financial Advisers LLP
Emily Staples	[phone]
Jo Turner	[phone]
Axis Capital Markets Limited
Richard Hutchison	[phone]
Acuitas Communications	020 3745 0293 / 07799 767676
Simon Nayyar	[e-mail]
Arthur Dingemans	[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 initially 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. The global market for CIPN alone is currently forecast to reach US$1.17bn by 2028.

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 five hundred derivatives and intellectual property rights including fourteen 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.

 

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