Objective This project will undertake preclinical and clinical research of the Orphan Drug Polihexanide (PHMB). The main objective is to provide a safe and effective drug for the treatment of the rare ocular disease Acanthamoeba keratitis (AK) tested according to international regulatory standards. This debilitating infectious disease is caused by a free living protozoan which, in the absence of treatment, can have catastrophic consequences such as severe pain, visual loss and eye enucleation. There are no approved drugs to treat this disease. After Orphan Drug Designation Protocol Assistance was requested from the European Medicines Agency on our drug development research plan. The proposed protocol incorporates the EMA advice and will include a non-clinical phase, a double-blind placebo controlled Phase I trial and a randomised double-blind, active controlled, parallel groups Phase 3 study (efficacy and safety therapeutic confirmatory study). The primary deliverables will be: 1) experimental scientific evidence on the quality, safety and efficacy of PHMB to provide the basis for a Marketing Authorisation within 5 years; 2) recommendations aiming to improve clinical practices in the management of AK based on the efficacy and safety evidence. ODAK is an industry led project mobilising the critical mass of industrial, pharmaceutical and academic expertise. needed to develop and optimise therapeutic approaches to alleviate the severe negative impacts of AK on the health and quality of life of patients. In particular, through identifying optimal PHMB formulations and recommending the best dose-benefit treatment regimes. ODAK directly contributes to the International Rare Diseases Research Consortium goal towards 200 new therapies. An estimated 95% of the total estimated EU contribution to the project will go to industrial partners (of this 32% goes to SMEs). The industrial strength assures a rapid translation of research to market application. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverymedical and health scienceshealth sciencesinfectious diseases Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2012.2.4.4-1 - Preclinical and/or clinical development of substances with a clear potential as orphan drugs Call for proposal FP7-HEALTH-2012-INNOVATION-1 See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator UNIVERSITE DE ROUEN NORMANDIE EU contribution € 273 800,00 Address RUE THOMAS BECKET 1 MONT SAINT AIGNAN 76821 Mont Saint Aignan Cedex France See on map Region Normandie Haute-Normandie Seine-Maritime Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (5) Sort alphabetically Sort by EU Contribution Expand all Collapse all S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA Italy EU contribution € 716 503,00 Address VIA ERCOLE PATTI 36 LAVINAIO 36 95025 ACI SANT ANTONIO CT See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data RESEARCH TOXICOLOGY CENTRE - SPA Italy EU contribution € 233 353,00 Address VIA TITO SPERI 12/14 00040 POMEZIA (Roma) See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST United Kingdom EU contribution € 117 750,00 Address CITY ROAD 162 EC1V 2PD London See on map Region London Inner London — East Haringey and Islington Activity type Research Organisations Links Contact the organisation Opens in new window Total cost No data PSR Group BV Netherlands EU contribution € 2 437 169,00 Address Planetenweg 5 2132 HN HOOFDDORP See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CERATIUM LIMITED United Kingdom EU contribution € 271 680,00 Address THE HAVEN 20 BURLINGHAM AVENUE CH48 8AP West Kirby See on map Region North West (England) Merseyside Wirral Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data