The FAIR project, which aimed to pave the way for the first-in-human phase I clinical trial with nebulized flagellin, is now entering the final stage after a successful 18 months of progress.
The final phase will include dissemination activities and see the start of the clinical trial.
Project Coordinator, Jean-Claude Sirard attributed the project’s success over the last 18 months to the commitment and determination of all partners involved.
“The FAIR project has achieved substantial progress in paving the way for the first-in-human phase I clinical trial with nebulized flagellin. I am thrilled by the commitment demonstrated by our partners in conducting impressive preclinical studies, modeling toxicology dosing, and establishing unique assays tailored for the clinical trial. The ongoing stratification of pneumonia patients will enable the development of personalized medicine, specifically targeting the more vulnerable individuals. Additionally, social and economic science research is integrating the FAIR project into society, providing essential added value for future applications. Personally, I found immense value in engaging with contributors to FAIR's daily activities, including PhDs, postdocs, and technicians.”
The main achievements in the past 18 months include:
- The production of clinical-grade immunomodulatory Flagellin (FLAMOD) for the clinical trial has been completed, with ongoing stability being maintained.
- The regulatory toxicology studies have begun and are nearing completion.
- Pre-clinical results on the adjunct FLAMOD treatment to boost antibiotic therapy have been obtained for several models of bacterial pneumonia, and are now in the dissemination and exploitation phase in support of the clinical trial.
- The toxicology and pre-clinical results have been consolidated into the ModSim modelling framework for PK/PD to optimize the study design for the clinical trial.
- The clinical trial application package (including the Investigator's Brochure [IB] and the Investigational Medicinal Product Dossier [IMPD]) is in preparation.
- Novel methods for stratification of pneumonia patients have been developed and are being validated for their potential in identifying patients who could benefit from adjunct FLAMOD therapy.
- Surveys on acceptability of nebulized FLAMOD by patients and clinicians have been completed. Results are in favor of good prospective acceptability.
- The mapping review of literature to inform for the economic model have been completed and results submitted for publication.
The FAIR project is now entering its final stage, featuring dissemination activities and the phase I clinical trial. The main objectives in 2024 are:
- Completion of the regulatory toxicology studies
- Submission of the clinical trial application package
- Initiation of the phase I clinical trial
- ERS online course on nebulized drugs
- Presentation of the FAIR achievements at the ERS International Congress 2024, in Vienna (September 7-11)