Celadon Pharmaceuticals has said it is now nearing completion of all preparatory work ahead of GMP inspection by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which it expects to take place in the second half of this year.
Following Celadon’s admission to the AIM in March this year, the company has provided an update on its operations.
Celadon says it believes it will become one of the first organisations in the UK to be licensed to sell GMP standard API, high THC medical cannabis from its Midlands facility if it completes a successful MHRA inspection.
A successful inspection will set the facility potentially receive MHRA registration and the grant of a further licence from the Home Office permitting supply for manufacture into finished medicinal products.
The company has also confirmed that it has successfully completed its sixth harvest from its Phase 1 grow facility.
Read more: New partnership to improve medical cannabis patient services
CEO of Celadon, James Short, commented: “We are pleased to report on our significant progress since Admission, which has seen Celadon advance all the necessary preparatory work to be in position for an MHRA inspection and continue the preliminary works for the build-out of its Phase 2 grow facilities.”
The Phase 2 facility is set to become operational by Q1 2023. The company has been working closely with the Home Office and has been successful in its application to expand its Home Office licence, which now allows for increased permitted storage of cannabis products at its Midlands based facility, and has received the necessary approvals to export its cannabis products for the purposes of analytical testing.
Adding to these developments, the company says that its private clinic subsidiary, LVL, the has received approval from Research Ethics Committee (REC) allowing for a 100-patient feasibility study of medical cannabis in patients with non-cancer chronic pain.
The feasibility study is designed to demonstrate the ability to engage and retain patients and will allow LVL to carry out an in-depth evaluation of the patient pathway. Enrolment of patients has already begun.
Initial patient onboarding data will be used in the feasibility study, and in the MHRA conditionally approved patient trial, for presentation to the National Institute for Clinical Excellence (NICE). The company has stated that initial feedback from patients who have received treatment has been positive, with improvements in quality of life being noted.
LVL also received Care Quality Commission approval for its physical clinic on Harley Street in London in order to operate that clinic, and the physical clinic is now able to see patients face to face.
Short continued: “Alongside our grow activity, I am delighted to report that LVL has been experiencing significant levels of new enquiries from those looking to participate in the chronic pain study.
“The LVL team is working hard to keep pace with patient onboarding as we continue to advance towards our objective of conducting what we believe would be the UK’s only MHRA approved clinical trial exploring the use of medical cannabis for the treatment of chronic pain.
“We believe that our highly regulated, pharmaceutical approach is the most effective route to ensuring that patient needs are met.
“With our focus on evidence-based data, facilitated by our medical cannabis study and MHRA conditionally approved medical cannabis trial, we hope to demonstrate the safety and efficacy of cannabis-based medicines, underpinning the case for regulatory approval and, in turn, reimbursement by the NHS.”
[activecampaign form=31]
