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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ARMOURY (Arthroscopic Regenerative Medicine for Early-Stage Treatment of OA)

Teaser

Summary

Osteoarthritis (OA) affects about 10% of the population. It has a major impact on a patientâ€™s quality of life; with pain and physical function being worse than chronic obstructive pulmonary disease or even cardiovascular disease. Its prevalence is increasing; by 2020 it will be the 4th leading cause of disability. OA is caused by â€˜wear and tearâ€™ and currently only symptoms are treated using pain killers until major surgery is needed, then the joint is replaced. Although joint replacement has improved and often last over 30 years, they do fail with about 10% of all joint replacement operations being to fix a failed implant.

The overall objective of the ARMOURY project was to explore the commercial feasibility of a new cell-based treatment for early-stage osteoarthritis (OA). This treatment includes combining: 1) a single-stage Advanced Therapeutic Medical Product (ATMP) tested in the knee and shown to be both safe and efficacious in Phase II clinical trial; and 2) new arthroscopic instrumentation called Hummingbird that allows access to the joint surface of the hip for preparation, tissue harvest and final delivery of prepared cells.

The specific objectives of this feasibility study were to: 1) a fully-define regulatory map for approval of the ATMP for the EU, (with recommendations for a future FDA submission); 2) fully-plan first-in-human study with written report on the scientific meeting with the MHRA, to form part of the regulatory approval process; 3) develop a Target Product Profile that includes an assessment of reimbursement price potential; 4) detail specification and work-package definitions of a full Health Economics study; 5) conduct a current competitor analysis; 6) report on the patent landscape detailing the freedom-to-operate; 7) develop the IP regime; 8) detail a business plan, including: cost of goods, margins from potential price, ramp-up of sales from proposed roll-out, and return on investment; 9) conduct a Risk Assessment of the overall innovation project, which will form the live Risk Registry for future project phases; 10) detail a plan for full User Engagement; and 11) outline a proposal for an Advisory Board with specific individuals for the study recommended.

Work performed

During this project JRI worked with University Medical Center Utrecht (UMCU), The Netherlands, and the Cell and Gene Therapy Catapult (CGT), UK, to explore the possibility of a commercial launch of the new treatment of OA in the hip. This targets the disease at an early stage when it appears as a distinct lesion. JRI has its own hip system, Hummingbird that can get into the complex anatomy of the hip and precisely cut out patches of diseased tissue. We studied a cell-based treatment developed by UMCU that they had successfully used to treat OA in the knee to see if it could be used with Hummingbird.

This feasibility study showed that, while the UMCU treatment is technically possible with Hummingbird, it is not commercially sustainable in its current form for JRI. However, JRI found a simpler version of this therapy that can be performed faster and will cost less to develop, which they will look to launch this. Working with the CGT, the next phase will involve a first-in-human study: a critical step in meeting the regulations and launching this new cell-based treatment hip.
Although the initial therapy studied by this Feasibility Study proved to be uncommercial, it should still be seen as a great success because it has defined a cell-based therapy that is more commercially suitable.

Final results

The expected outcomes of the new treatment will include: 1) improved quality of life (QoL) of patients with early-stage OA of the hip; 2) reduced demands on society from the burden of the disease on patients and their carers; 3) lowered cost to healthcare systems through earlier and improved intervention; and 4) an established business model for ATMPs that is cost effective and commercially sustainable.

Industrial/economic/social problem to be solved: with the high prevalence of OA (8.75 million people in the UK and 30 million in Europe), the impact on society is high . The creation of new therapies that allow OA to be treated at an earlier stage than is currently possible will alleviate this impact.