CORDIS
EU research results

CORDIS

English EN
Orphan Drug for Acanthamoeba Keratitis

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.
Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

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)

Sort alphabetically

Sort by EU Contribution

Expand all

S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA

Italy

EU Contribution

€ 716 503

RESEARCH TOXICOLOGY CENTRE - SPA

Italy

EU Contribution

€ 233 353

MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 117 750

PSR Group BV

Netherlands

EU Contribution

€ 2 437 169

CERATIUM LIMITED

United Kingdom

EU Contribution

€ 271 680

Project information

Grant agreement ID: 305661

Status

Closed project

  • Start date

    1 December 2012

  • End date

    30 November 2017

Funded under:

FP7-HEALTH

  • Overall budget:

    € 5 779 906,80

  • EU contribution

    € 4 050 255

Coordinated by:

UNIVERSITE DE ROUEN NORMANDIE

France