Pan-European APPROACH project receives 15 million Euro research funding to find the right osteoarthritis medicine for the right patient
In a bid to stimulate the development of much needed treatments for osteoarthritis, a consortium of 24 partners comprising pharmaceutical companies, biotech companies, academic institutions, not-for-profit organizations, small and medium enterprises (SMEs) and public bodies have joined forces in the pan-European APPROACH (Applied Public-Private Research enabling OsteoArthritis Clinical Headway) project, with total research funding of 15 million Euros. Of this amount, 7.5 million Euros will come from the European Innovative Medicines Initiative (IMI) and 7.5 million Euros in the form of ‘in kind’ contributions from participating members of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
It is estimated that worldwide around 9.6% of men and 18% of women over the age of 60 years experience the debilitating symptoms of osteoarthritis*, yet drug development for the disease has so far been disappointing due, in part, to complexities around identifying the right patients to treat. The APPROACH consortium will combine biomedical data for >10,000 patients and controls from nine existing cohorts into a unified bioinformatics platform. It will use this platform to generate several well-defined targetable patient subsets based on existing and newly developed biomarkers. Validation and qualification of the diagnostic tools will be performed in a 500-patient longitudinal study. The results of this 5.5 year program will be used to support the selection of patient cohorts for new disease modifying osteoarthritis drug (DMOAD) clinical trials. Ultimately, the identification of patients who are most likely to respond to a given treatment, should lead to improved drug development and diagnostic / prognostic tools that allow osteoarthritis patients to receive highly personalized treatment.
GSK will be the coordinator of the consortium, the University Medical Center Utrecht (UMCU, The Netherlands) will be the co-coordinator, and CTMM-TI Pharma (a merger of the Dutch CTMM and TI Pharma Top Institutes) was chosen as the independent managing organization because of its unique experience in coordinating large-scale public-private partnership translational medical research in the Netherlands over the last nine years.
“In addition to a unique and comprehensive set of OA patient data, the APPROACH consortium brings together a diverse set of highly regarded experts in the field to develop, validate and link biomarkers with biological processes and clinical endpoints. Ultimately, this will increase efficiency in clinical trial design and interpretation leading to regulatory qualification and personalised medicines to treat this serious disease”, said Dr. Jonathan Larkin, APPROACH Coordinator and Senior Scientific Investigator at GSK.
Harrie Weinans, professor of Tissue Biomechanics and Implants, at the Dutch University Medical Center Utrecht, and APPROACH Co-coordinator, says “this consortium blends clinical centre expertise on patient care and cohort studies and provides cutting edge imaging technology, biochemical assays, omics platforms and human motion analysis expertise. In addition, state-of-the-art facilities are available within our industrial partners and the clinical hospitals, including GLP certified labs, enabling a unique approach that allows us to make a big leap forward in this field”.
Scientific Director of CTMM-TI Pharma, Professor Peter Luijten, said, “By bringing together European expertise in drug development, medical imaging and biomarker discovery, the APPROACH project will develop the companion diagnostics that will be needed for targeted osteoarthritis drugs to be used most effectively.”