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Orphan Drug for Acanthamoeba Keratitis

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.

Field of science

  • /social sciences/economics and business/business and management/commerce

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
Address
Rue Thomas Becket 1 Mont Saint Aignan
76821 Mont Saint Aignan Cedex
France
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 273 800
Administrative Contact
Philippe Moguérou (Dr.)

Participants (5)

S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA
Italy
EU contribution
€ 716 503
Address
Via Ercole Patti 36 Lavinaio 36
95025 Aci Sant Antonio Ct
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Antonino Asero (Mr.)
RESEARCH TOXICOLOGY CENTRE - SPA
Italy
EU contribution
€ 233 353
Address
Via Tito Speri 12/14
00040 Pomezia (Roma)
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Morena Cascone (Dr.)
MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 117 750
Address
City Road 162
EC1V 2PD London
Activity type
Research Organisations
Administrative Contact
Nick Precious (Mr.)
PSR Group BV
Netherlands
EU contribution
€ 2 437 169
Address
Planetenweg 5
2132 HN Hoofddorp
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Roger Legtenberg (Dr.)
CERATIUM LIMITED
United Kingdom
EU contribution
€ 271 680
Address
The Haven 20 Burlingham Avenue
CH48 8AP West Kirby
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ritchie Head (Dr.)