OXFORD Cannabinoid Technologies Holdings plc (OCTP), the holding company of Oxford Cannabinoid Technologies Ltd (OCT), a pharmaceutical company developing prescription cannabinoid medicines for approval by key medicines regulatory agencies worldwide and targeting the US$ multi-billion pain market, announces the signing of new partnerships to target trigeminal neuralgia (TN) – an increasingly prevalent chronic pain condition.
TN, which is also known as tic douloureux, is a chronic pain condition that affects the trigeminal nerve producing an excruciating, stabbing, electric shock-like pain. A patient may experience up to 100 attacks per day, with a constant throbbing, aching or burning sensation between attacks. About 150,000 new cases of TN are diagnosed each year, and in 2021 there were over 65,000 cases in the UK.
With current treatments only partially effective and with adverse side-effects, OCT aims to provide a drug-device combination product for sufferers and has signed a number of service agreements to accelerate development.
The Group’s TN product concept is a combination of unnamed phytocannabinoids (pCBs) that will be administered to the lungs using a simple metered dose inhaler. Administration to the lungs should reduce onset time and the extensive first-pass metabolism associated with oral administration of cannabinoids.
The Group aims to obtain Orphan Drug Designation (ODD) which will allow OCTP to retain market exclusivity through regulatory protections, and may reduce time and cost to market. The programme is designed for an accelerated route to first-time-in-human (FTiH) with Phase 1 clinical trials planned for Q3 2022.
Supply Agreements
Purisys
A new supply agreement with Purisys LLC (“Purisys”)(Athens, GA, USA) secures ultra-high purity, cannabinoid active pharmaceutical ingredients (“APIs”) for the current preclinical drug development and future clinical and commercial supplies for the Group’s Programme 2. Purisys has an industry-leading track record of more than a decade producing cannabinoid APIs under commercial drug master files (DMFs) that have been successfully referenced in registered pharmaceutical marketing applications. Purisys operates in full compliance with global regulatory pharmaceutical standards and utilizes its DMFs as well as extensive regulatory experience to aid pharmaceutical companies in gaining regulatory approval of new and improved therapies to treat, cure, or prevent disease.
Oz-UK Ltd
In addition, OCTP has entered into a commercial agreement with Oz-UK Ltd, Corsham, UK, for the development of a cannabinoid metered dose inhaler formulation, which will include studies aiming to identify and define the excipient/formulation components, as well as the selection of the canister, valve, and actuator. The selected formulation and device aim to deliver high-purity cannabinoids through the inhalation route which will allow faster and more efficient absorption of the APIs intended to provide both short and long term relief from neuralgias.
Voisin Consulting Life Sciences (“VCLS”)
In order to enable the development and regulatory strategy of the Group’s combination product, it has entered a further work package under the agreement with VCLS previously announced on 1 June 2021. VCLS is a global leader in supporting pharmaceutical, biotech and medtech partners in expediting access of healthtech products to regulated markets. VCLS will provide support to define nonclinical risk and gap analysis, regulatory strategy and roadmap, as well as clinical development strategy.
Dr John Lucas, Chief Executive Officer of OCTP, said: “We are delighted to have further expanded our portfolio. The pain caused by TN can be extremely debilitating and we are looking forward to working towards a pain management solution with our partners. We remain focused on developing our portfolio and increasing our growth potential as we progress our drug development programmes through preclinical and clinical trials.”
