Descrizione del progetto
Terapia con aerosol di flagellina nel trattamento della polmonite batterica resistente ai farmaci
La polmonite batterica è una delle principali cause di morbilità e mortalità in tutto il mondo. L’assistenza standard con antibiotici è spesso complicata dalla resistenza agli antimicrobici, con conseguente insuccesso terapeutico. Il progetto FAIR, finanziato dall’UE, mira a valutare un’aggiunta alla terapia antibiotica come concetto emergente per superare la resistenza agli antimicrobici nella polmonite. La ricerca si concentra sul peculiare immunomodulatore flagellina che migliora le difese immunitarie innate epiteliali delle vie aeree e sullo sviluppo dell’erogazione di aerosol specifico per le vie aeree mediante nebulizzazione. Gli obiettivi principali di FAIR includono l’ottimizzazione della nebulizzazione e la dimostrazione del miglioramento della risposta antibiotica associato alla flagellina, nonché l’ottenimento di modelli di farmacocinetica e farmacodinamica per la convalida clinica e la valutazione della sicurezza della nebulizzazione di flagellina in una sperimentazione clinica di Fase I.
Obiettivo
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.
Campo scientifico
- medical and health sciencesclinical medicinepneumology
- medical and health scienceshealth sciencespublic health
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibiotics
- medical and health sciencesbasic medicinepharmacology and pharmacypharmacokinetics
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistanceantibiotic resistance
Parole chiave
Programma(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SC1-2019-Two-Stage-RTD
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
75654 Paris
Francia