The Partnership between the FNIH and Bioibérica Farma will Boost Research on Osteoarthritis Biomarkers

The U.S. Foundation of the National Institutes of Health (FNIH) and Bioiberica Farma have signed a scientific partnership agreement to support OA biomarkers research. Their major objective is the research and validation of a number of biochemical (blood and urine) and imaging biomarkers used to diagnose knee OA prior to the development of symptoms, to identify those individuals with a more severe prognosis, to predict the evolution of the disease, and to assess the efficacy of the treatments.

To do so, they will have at their disposal the resources of the National Institutes of Health (NIH). To be more precise, these resources consist of the Osteoarthritis Initiative (OAI): a repository of images, patient’s clinical records and biological samples. Using this database, researchers will be able to evaluate the capabilities of a range of biochemical and imaging biomarkers by means of radiographic analysis, magnetic resonances and blood/urine samples. Subsequently, the researchers will try to validate biomarkers and to determine how quickly they change over time.

The project will be carried out over the next two and a half years via an international team of physicians and scientists with an expertise in osteoarthritis, under the auspices of The Biomarkers Consortium, a public-private body administered by the FNIH. The researchers team will be headed by Professor David Hunter, clinical rheumatology researcher at the University of Sidney, and by Dr. Virginia Byers Kraus, rheumatologist and Assistant Professor of Medicine at the University of Duke (Durham, North Carolina, EE.UU.)

OA is a chronic, inflammatory and degenerative disease affecting joints. It causes loss of cartilage, inflammation of the synovial membrane and remodeling of the subchondral bone. Dr. Byers Kraus highlights that “knee osteoarthritis might affect people of any age group, and is one of the major causes of physical disability in adults. Moreover, during the coming years it is expected that the number of OA patients will double due to population aging, increased sports playing, and obesity. The main symptoms of this disease are pain and functional disability.” 

Currently, one of the major problems is the difficulty of its early detection because of the lack of biomarkers to assess its onset and progression. This is why Professor Hunter has declared that “This project holds unbelievable potential. If we upgrade our ability to predict and control OA progression, we will be able to intervene earlier, thus improving the patient quality of life. The biomarkers that we will identify will be useful to classify patients depending on their risk of suffering OA, to measure the clinical progression of the disease, and to develop new treatments to delay its evolution”.

Dr. Josep Vergés will be the representative of Bioibérica Farma at the scientific board of the project. Dr. Vergés is a clinical pharmacologist and Medical and Scientific director of Bioiberica Farma. “The mission of Bioibérica Farma is to improve the quality of life of OA patients, which is a mission that we share with the FNIH. With our collaboration, we want to emphasize our commitment with personalized medicine research, thus achieving better diagnosis and treatment for this disease; a disease which affects more than seven million Spaniards. Moreover, OA biomarkers will help us to identify which patients respond to the treatment, something of vital importance given the context of the economic crisis and healthcare budgetary cuts we are in”, said Dr. Vergés.

The research team of The Biomarkers Consortium includes experts from the National Institutes of Health, from the Food and Drug Administration (FDA), biotech and pharmaceutical companies, academic institutions and non-profit organizations. Among the latter, there are the following: Abbott; Amgen Inc.; Arthritis Foundation; Bioiberica S.A.; DePuy Mitek, Inc.; Flexion Therapeutics, Inc.; GlaxoSmithKline; Merck Serono; Rottapharm | Madaus; Sanofi; and Stryker. Additional collaborators are: Alere Inc.; ARTIALIS S.A.; BioVendor – as well as the medial laboratories of; IBEX Pharmaceuticals Inc.; Immunodiagnostic Systems Ltd; and Quidel Corporation.

The FNIH was created in 1999 by the US Congress to support the mission of the NIH, that is, the improvement of public health, and to encourage scientific cooperation between universities, industry, and other nonprofit organizations. Since then, the Foundation has managed to gather the best researchers, thus becoming the world leader in biomedical and healthcare research. For additional information, see www.fnih.org.

The Biomarkers Consortium is a public-private body dedicated to biomedical research which is managed by the FNIH. The Biomarkers Consortium strives to develop and validate biomarkers in order to accelerate the development of drugs and therapies for the detection, prevention and treatment of disease, as well as improving patient care.

Prevention, diagnosis, and treatment of OA. These are the three major pillars of Bioibérica Farma, the only Spanish company specializing in the research and development of medicines and therapies useful for a comprehensive approach to OA treatment. Of note, it is a worldwide reference in the field of chondroprotection, that is, in the prevention, diagnosis and treatment of cartilage, synovial membrane and subchondral bone injuries. In recent years, Bioibérica Farma has opted to strongly support personalized medicine research, i.e., to develop products which, based on the genetic and/or environmental data of an individual, will diagnose, prevent or treat a given disease. This is why Bioibérica Farma, in a joint project with the University of Liège, rheumatologists specializing in OA, and the Belgian government, created the Artialis spin-off for the development of OA biomarkers.