Approval to roll-out chronic pain clinical trial

Celadon Pharmaceuticals PLC

01 August 2023

 

Celadon Pharmaceuticals Plc

("Celadon" or the "Company")

Approval to roll-out chronic pain clinical trial

London, 1 August 2023 - Celadon Pharmaceuticals Plc (AIM: CEL), a UK-based pharmaceutical company focused on the research, cultivation, manufacturing and sale of breakthrough cannabis-based medicines, announces that LVL Health, its private pain clinic, has received approval from the National Health Service ("NHS") Research Ethics Committee  to roll-out its non-cancer chronic pain clinical trial for up to 5,000 patients (the "Trial").

The Company previously held conditional approval from the Medicines and Healthcare products Regulatory Agency ("MHRA") for the Trial, however before formally commencing the Trial, the NHS's Ethics Committee requested an initial Feasibility Study to be conducted over a three-month period.  The results of the Feasibility Study were submitted for review on 30 December 2022 (as announced by the Company) and indicated positive outcomes for quality of life, pain and sleep, as well as the reduction of opioid usage.

As an approved Trial, it is believed to be the only one of its kind in the UK, and is designed to create a data set that will support doctors' prescriptions of cannabis-based medicines, and in time enable potential reimbursement by the NHS and insurance companies. It also enables General Practitioners to prescribe the medicine to patients in addition to specialist doctors, and organisations such as charities can advertise recruitment for the Trial. The Company believes this to be a major advance in enabling much wider access for patients, ultimately leading to the opening up of the UK market for cannabis-based medicines.

The Company is working with its partners to finalise the plan for the optimal and timely roll-out of the Trial.

James Short, Chief Executive Officer of Celadon, said:

"We are delighted that our clinical trial has received its approvals and we can now start the important work of getting our medicine to patients. Everything we do at Celadon starts with the patient, and the results from the first part of the study we have seen in terms of improvements in quality of life have been tremendous.

"Our longstanding aim remains to open up the UK market by giving doctors confidence in prescribing and creating the most robust data set to-date in the UK for cannabis-based medicines. This is why we invested in LVL and the trial protocol in the first place, which was over two years in development.

"This larger clinical trial was designed in collaboration with the MHRA to provide a data set that will enable the potential for prescription and reimbursement by the NHS and insurance companies."

Enquiries:

Celadon Pharmaceuticals Plc
James Short Arthur Wakeley Jonathan Turner	Via Powerscourt
Canaccord Genuity Limited (Nominated Adviser and Broker)
Bobbie Hilliam / Andrew Potts / Patrick Dolaghan	[phone]
Powerscourt Group
Sarah MacLeod / Nick Johnson / Sam Austrums / Ibrahim Khalil	[phone]

About Celadon Pharmaceuticals Plc

Celadon Pharmaceuticals Plc is a UK based pharmaceutical company focused on the research, cultivation, manufacturing, and sale of breakthrough cannabis-based medicines. Its primary focus is on improving quality of life for chronic pain sufferers, as well as exploring the potential of cannabis-based medicines for other conditions such as autism. Its 100,000 sq. ft UK facility is EU-GMP approved and comprises indoor hydroponic cultivation, proprietary GMP extraction and manufacturing and an analytical and R&D laboratory. Celadon's Home Office licence allows for the commercial supply of its GMP pharmaceutical cannabis product. The Company's subsidiary, LVL, owns a MHRA conditionally-approved clinical trial using cannabis based medicinal products to treat chronic pain in the UK. Celadon also has a minority interest in early-stage biopharma Kingdom Therapeutics which is developing a licenced cannabinoid medicine to treat children with Autism Spectrum Disorder.

For further information please visit our website www.celadonpharma.co.uk

This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014 as amended by regulation 11 of the Market Abuse (Amendment) (EU Exit) Regulations 2019/310. With the publication of this announcement, this information is now considered to be in the public domain.

 

END