RCS - Celadon Pharma. PLC - Early Economic Analysis of Feasibility Study Data

Celadon PharmaceuticalsAnnouncement

07/03/2024 07:00

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RNS Number : 8895F  Celadon Pharmaceuticals PLC  07 March 2024

 

Celadon Pharmaceuticals Plc

 

("Celadon", the "Group" or the "Company")

 

Early Economic Analysis of CANPAIN Feasibility Study Data

 

London, 7 March 2024 - Celadon Pharmaceuticals Plc (AIM: CEL), a UK-based
pharmaceutical company focused on the development, production and sale of
breakthrough cannabis-based medicines, is pleased to announce the results of
an early economic analysis of the data collected as part of the feasibility
study for its fully approved chronic pain clinical trial ("CANPAIN").

 

The analysis was undertaken by York Health Economic Consulting ("YHEC"), which
provides consultancy and research services in health economics. The findings
of YHEC's analysis are as follows:

 

-      Patients on the feasibility study recorded an almost 50% (49.6%)
reduction in pain scores in the first month of using cannabis-based medicines,
with this reduction in pain being sustained throughout the three-month study.

-      Patients saw a significant improvement in their mean quality of
sleep scores of 1.6 points (p=0.01) and a reduction in the use of opioids and
associated medicines.

-      When assessed using the economic framework recommended by NICE,
adding cannabis-based medicines to the Standard of Care was found to deliver a
cost-effective solution and, depending on the price point, a cost saving to
the National Health Service ("NHS")

-      Patients' quality-adjusted life years also increased.

 

Background

In October 2018, the UK's National Institute for Health and Care Excellence
("NICE") issued a call for evidence to evaluate the safety and clinical
efficacy of cannabis-based medicines for use in humans. In response, Celadon
drew up plans for its own clinical trial, which it called CANPAIN. In August
2023, following a three-month feasibility study, the NHS Research Ethics
Committee approved the CANPAIN trial for up to 5,000 patients.

After completing the feasibility study, Celadon commissioned YHEC to carry out
a comprehensive and independent review of the data generated, and to construct
an early economic model. YHEC's findings underscore the safety, tolerability
and effectiveness of Celadon's cannabis-based medicines when delivered via an
inhalation device for individuals suffering from non-cancer chronic pain.

 

These findings, which will be built on by the additional data generated by the
forthcoming CANPAIN trial, offer a solid foundation for Celadon's engagement
with NICE, the NHS and private health insurers in relation to the
reimbursement of the cost of cannabis-based medicine treatment. The data
represents a significant step towards fulfilling the unmet needs of the
millions of patients living with chronic pain in the UK, providing a potential
alternative to current treatments (including opioids).

Celadon remains committed to advancing healthcare solutions that improve
quality of life and reduce healthcare costs, and looks forward to the
commencement of its CANPAIN trial, which will provide the opportunity to
further demonstrate the value of its cannabis-based medicines in chronic pain
management.

 

James Short, CEO of Celadon Pharmaceuticals Plc, commented:

"We are incredibly proud to announce these highly encouraging results, which
show just how beneficial cannabis-based medicines could be to millions of
patients across the UK, whose needs are currently going unmet. This positive
data gives us even greater confidence in our forthcoming clinical trial, which
will involve up to 5,000 patients and see General Practitioners permitted to
prescribe cannabis-based medicines. Once completed, the NHS will have a proven
and cost-effective alternative for managing chronic pain, which we are
confident will break down the barriers to prescriptions in the UK.

"Our research has also identified additional conditions that could benefit
from cannabis-based medicines, significantly expanding the potential patient
pool well beyond our initial estimates of 8 million people in the UK alone.
This broader scope underscores the transformative potential of our work, and
is a momentous opportunity for Celadon, the NHS, and most importantly, for
patients. As far as we are aware, this is the only known trial responding
directly to the government's call for more comprehensive data on
cannabis-based medicines. I would encourage my colleagues across the industry
to follow our lead and gather the clinical data required to support NHS
prescriptions of cannabis-based medicines."

Enquiries:

 Celadon Pharmaceuticals Plc
 James Short                                               Via Powerscourt

 Jonathan Turner

 Canaccord Genuity Limited (Nominated Adviser and Broker)
 Bobbie Hilliam / Andrew Potts                             +44 (0)20 7523 8000

 Global Investment Strategy UK Limited (Joint Broker)                                                       +44 (0)20 7048 9400

 Callum Hill

 Powerscourt Group
 Sarah MacLeod / Sam Austrums / Nick Johnson                                                                +44 (0)20 7250 1446

 

About Celadon Pharmaceuticals Plc

Celadon Pharmaceuticals Plc is a UK-based pharmaceutical company focused on
the development, production 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 an
analytical and R&D laboratory. Celadon's Home Office licence allows for
the commercial supply of its pharmaceutical-grade cannabis product. The Group
owns an 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 licensed
cannabinoid medicine to treat children with Autism Spectrum Disorder.

 

For further information please visit our website www.celadonpharma.com
(http://www.celadonpharma.com)

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