Project: Development of the Mucosal Patch Technology as a diagnostic test for detecting inflammation in the bowel of IBS patients

AIM_x000D_The CO aim of this project is to develop the Mucosal Patch Technology (MPT) as a diagnostic test for colonic inflammation in IBS patients. The project will cover both developmental aspects, such as further development of the balloon catheter and identification / certification of new analytic methods, as well as clinical studies to establish clinical usefulness. The clinical study comprised within this project is one proof-of-concept study to study the efficacy of the MucoMPO tool for identification of colonic inflammation in IBS patients. The ultimate goal of this project is the release of the MPT technology and its applications on the market as a diagnostic tool. _x000D__x000D_BACKGROUND_x000D_IBS symptoms, range from mild to severe and can have serious impact on the quality of life of certain affected individuals. Despite the high prevalence; no specific therapy has yet been identified and current treatment is COly based on dietary control. The etiology of the condition reCOs up to this date inconclusive but growing evidence exists that in at least a subset of IBS patients there is low-grade inflammation. In light of these findings, prior placebo-controlled randomized studies with corticosteroids and acetylsalicylic acid have been performed but no significant differences to placebo were shown, possibly due to a lack of homogeneity for colonic inflammation in the treated patients._x000D__x000D_The Mucosal Patch System is a novel diagnostic method developed by the University of Uppsala. This technology can be applied for stratifying the IBS patient subset who has colonic inflammation by measuring the quantity of myeloperoxidase (MucoMPO test). As it is believed that this subset of patients can have their symptoms mitigated with anti-inflammatory drug treatment, this test could allow the physician to identify these patients and tailor the treatment accordingly. This test would also allow stratification of these patients in clinical trials, thus enabling studies with a more homogenous group. _x000D__x000D_TECHNICAL APPLICATIONS_x000D_Overall, the 4 work packages cover the following aspects:_x000D_1. Overall project management, including regulatory research, planning, execution, statistical planning and oversight_x000D_2. Develop the prototype MPT balloon catheter _x000D_3. The development of assays for two inflammatory ELISA tests_x000D_4. Establish clinical usefulness for the gastro-intestinal therapeutic area_x000D__x000D_MARKET APPLICATIONS_x000D_IBS is a truly global disease affecting a multitude of patients worldwide. According to previous studies around 15% of the general population presents with IBS symptoms, upon which approximately 20% will seek medical professionals for diagnosis. The market potential for a diagnostic tool for this disease is therefore huge. _x000D__x000D_CONSORTIUM_x000D_The Ps are selected based on complementary qualifications. The CO international P in the consortium is Alimenta Medical AB, a small medtech company originating in Stockholm, Sweden. Alimenta is the owner of the intellectual property of the technology on which the MucoMPO test is based and is a biopharmaceutical company engaged in the development of diagnostic technologies and analytical services for gastrointestinal diseases, food hypersensitivities, and food allergies. _x000D__x000D_Strengthening the consortium with their profound knowledge of the subject are the academic Ps from Karolinska University Hospital in Solna, Dr Hans Törnblom and Sahlgrenska University Hospital, Professor Magnus Simrén. With their complementary set of skills, Dr Törnblom specializing within the immunological aspects and Professor Simrén focusing on the symptomatology of the disease, they are an integral part of the planning and execution of the clinical study on IBS. _x000D__x000D_Diagnostics development P&M Venge AB is a privately held laboratory, whose core business is development and application of sensitive immunoassays for the diagnosis and monitoring of inflammatory disease; identification and purification of unique secretory protein molecules from inflammatory cells, production of poly- and monoclonal antibodies against these proteins, development of sensitive immunoassay as well as sales of antigens, antibodies and ELISA kits for unique secretory molecules from inflammatory cells. Diagnostics Development develops and CE-marks the inflammatory marker assays used in the project. Diagnostics Development will also act as core laboratory for the assay of samples obtained in the project._x000D__x000D_Smerud Medical Research is a Contract Research Organisation with more than 15 years experience in directing and managing clinical research projects, in particular early phase studies or clinical proof-of-concept trials. The Smerud CRO has top level competence in advanced medical statistics, including adaptive design expertise and are responsible for commercialisation (clinical development until marketing authorisation is obtained) of several early phase compounds for the biotech industry._x000D_

Acronym MucoMPO (Reference Number: 5691)
Duration 01/10/2010 - 31/08/2015
Project Topic This project is aimed at further development of the Mucosal Patch Technology and confirmation of its applications in irritable bowel disease - with an ultimate aim of releasing the device on the market as a diagnostic tool.
Network Eurostars
Call Eurostars Cut-Off 4

Project partner

Number Name Role Country
5 Karolinska University Hospital Solna, Dept of Gastroenterology and hepatology Partner Sweden
5 Diagnostics Development, P&M Venge AB Partner Sweden
5 Sahlgrenska University Hospital, Dept of Internal medicine Partner Sweden
5 Alimenta Medical AB Coordinator Sweden
5 Smerud Medical Research International AS Partner Norway