Project description DEENESFRITPL Flagellin aerosol therapy in treatment of drug-resistant bacterial pneumonia Bacterial pneumonia is a leading cause of morbidity and mortality worldwide. Standard care with antibiotics is often complicated by antimicrobial resistance (AMR), resulting in curative failure. The EU-funded FAIR project aims to assess an adjunct to antibiotic therapy as an emerging concept to overcome AMR in pneumonia. The research focuses on the unique immunomodulator flagellin that enhances airway epithelial innate immune defences, and the development of airway-specific aerosol delivery by nebulisation. FAIR's main objectives include optimisation of nebulisation and demonstration of flagellin-associated enhancement of the antibiotic response, as well as obtaining pharmacokinetics and pharmacodynamics models for clinical validation and assessing flagellin nebulisation safety in a Phase I clinical trial. Show the project objective Hide the project objective Objective Bacterial pneumonia is a leading cause of morbidity and mortality worldwide. Antibiotics constitute the standard of care but are faced with the emergence of antimicrobial resistance (AMR) and the curative failure. The FAIR consortium aims at assessing an adjunct to antibiotic therapy as an emerging concept of overcome AMR in pneumonia. The project leverages (i) a unique immunomodulatory flagellin that enhances airway epithelial innate immune defences and increases the therapeutic outcome relative to antibiotic alone, and (ii) airway-specific aerosol delivery by nebulization.FAIR’s objectives are to:• develop nebulization modalities for optimal airway targeting and rapid action at the infection site• demonstrate that nebulized flagellin strengthens the response to antibiotics in relevant preclinical models of antibiotic-resistant pneumonia• identify host immune factors required for the gain of protection with systems biology• implement pharmacokinetics/pharmacodynamics model-based design and simulation for clinical validation• assess nebulized flagellin’s safety in a Phase I clinical trial.• analyze the acceptability and economic relevance of the therapy• identify stratification markers that predict the course of pneumonia and treatment in antibiotic-treated cohorts.Expected outcomes include the enrichment of the pipeline of novel treatments against pneumonia, reinforcement of EU capacity to control AMR and infections, the Phase I safety report on nebulized flagellin, recommendations for future trials, and acceptability by the stakeholders and cost-effectiveness for public health. FAIR will develop new avenues of research on mechanisms of action of the adjunct flagellin, and will define (for future trials) the subpopulation of patients that might benefit most from this treatment. Our industrial partnerships and exploitation plan will enable straightforward development of drug and nebuliser device, and bring innovation to the patients. Fields of science medical and health sciencesclinical medicinepneumologymedical and health scienceshealth sciencespublic healthmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibioticsmedical and health sciencesbasic medicinepharmacology and pharmacypharmacokineticsmedical and health sciencesbasic medicinepharmacology and pharmacydrug resistanceantibiotic resistance Keywords Innate immunity Toll-like receptor nebulization pneumonia antimicrobial resistance antibiotic phase I clinical trial Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-BHC-14-2019 - Stratified host-directed approaches to improve prevention, treatment and/or cure of infectious diseases Call for proposal H2020-SC1-BHC-2018-2020 See other projects for this call Sub call H2020-SC1-2019-Two-Stage-RTD Funding Scheme RIA - Research and Innovation action Coordinator INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Net EU contribution € 2 082 152,95 Address Rue de tolbiac 101 75654 Paris France See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (14) Sort alphabetically Sort by Net EU contribution Expand all Collapse all Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES France Net EU contribution € 606 121,59 Address Rue leblanc 25 75015 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. UNIVERSITE DE TOURS France Net EU contribution € 149 325,00 Address Rue du plat d etain 60 37020 Tours See on map Region Centre — Val de Loire Centre — Val de Loire Indre-et-Loire Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. INSTITUT PASTEUR DE LILLE FONDATION France Net EU contribution € 318 750,00 Address Rue du professeur calmette 1 59019 Lille See on map Region Hauts-de-France Nord-Pas de Calais Nord Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 INSERM TRANSFERT SA France Net EU contribution € 247 875,00 Address 10 rue d'oradour-sur-glane - parisante campus 75015 Paris See on map Region Ile-de-France Ile-de-France Paris 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 Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 FREIE UNIVERSITAET BERLIN Germany Net EU contribution € 507 750,00 Address Kaiserswerther strasse 16-18 14195 Berlin See on map Region Berlin Berlin Berlin Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EPITHELIX SARL Switzerland Net EU contribution € 482 896,16 Address Chemin des aulx 14 1228 Plan les ouates See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Schweiz/Suisse/Svizzera Région lémanique Genève 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 Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 AEROGEN LTD Ireland Net EU contribution € 196 625,00 Address Ida business park dangan H91 Galway See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ireland Northern and Western West Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 STATENS SERUM INSTITUT Denmark Net EU contribution € 3 133 723,05 Address Artillerivej 5 2300 Kobenhavn s See on map Region Danmark Hovedstaden Byen København Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS France Net EU contribution € 604 989,00 Address Boulevard tonelle 2 37044 Tours cedex 9 See on map Region Centre — Val de Loire Centre — Val de Loire Indre-et-Loire Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM Netherlands Net EU contribution € 1 251 170,00 Address Meibergdreef 15 1105AZ Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITE DE LILLE France Net EU contribution € 174 086,56 Address 42 rue paul duez 59000 Lille See on map Region Hauts-de-France Nord-Pas de Calais Nord Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITY OF SOUTHAMPTON United Kingdom Net EU contribution € 275 064,44 Address Highfield SO17 1BJ Southampton See on map Region South East (England) Hampshire and Isle of Wight Southampton Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EUROPEAN RESPIRATORY SOCIETY Switzerland Net EU contribution € 68 625,00 Address Avenue sainte luce 4 1003 Lausanne See on map Region Schweiz/Suisse/Svizzera Région lémanique Vaud Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. EUROPEAN LUNG FOUNDATION United Kingdom Net EU contribution € 63 750,00 Address Glossop road 442 S10 2PX Sheffield See on map Region Yorkshire and the Humber South Yorkshire Sheffield Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00