FAIR project makes substantial progress despite pandemic pitfalls

    FAIR project makes substantial progress despite pandemic pitfalls

    FAIR project makes substantial progress despite pandemic pitfalls

     

    Despite the hurdles presented by the COVID-19 pandemic, the FAIR project has continued to progress and achieve many milestones, thanks to the commitment of the project team and partners.

    Jean-Claude Sirard, FAIR project coordinator noted: “The progress of the FAIR project has been excellent despite the COVID-19 context that the project has had to face since the very beginning. Weekly video conferences with partners have been/are instrumental to setting the course and goals of the project. We were delighted to have our first face-to-face annual meeting in June this year. I particularly appreciated meeting the partners in person, especially the PhD, postdocs and technicians who are integral players in the daily FAIR activities.”

    Milestones to date have included:

    • the development of an inhaled formulation of Flagellin
    • the production of clinical-grade immunomodulatory Flagellin (FLAMOD) is well underway in preparation for the clinical trial
    • the first toxicology studies on preclinical models including human primary airway epithelium have been conducted
    • the hypothesis of boosting antibiotic therapy with FLAMOD has been consolidated in preclinical models of bacterial pneumonia
    • the framework for modelling the PK/PD and the dose of FLAMOD is setup and will be applied for toxicology and clinical studies
    • a retro planning agenda is in place and fruit full interactions between sponsor, investigator, and partners have been developed for the phase 1 clinical trial
    • cohorts of pneumonia patients have started to be included for stratification purposes
    • acceptability of nebulized FLAMOD has started to be studied via online surveys and in focus groups
    • the mapping review for the economic model has been generated and the systematic review is ready to start
    • ethical evaluation of the whole project has been successfully approved by EU thanks to the interest and respect of all partners.

    “I am excited by the next steps of the project and I am confident to start the phase 1 clinical trial in 2023.”

     

     

    Acknowledgement of partners and their involvement in achieving these milestones:

    The inhaled formulation of Flagellin (FLAMOD) has been developed to guarantee stability and biological activity during mesh-nebulization in humans.
    Nathalie Heuzé-Vourc'h
    Nathalie Heuzé-Vourc'h
    Alexie Mayor
    Alexie Mayor
    Jeofrey Pardessus
    Jeofrey Pardessus
    Ronan MacLoughlin
    Ronan MacLoughlin
    Statens Serum Institut (SSI) was tasked with producing clinical-grade immunomodulatory flagellin (FLAMOD). The team at SSI is pleased to report that the analytical methods for the release and stability testing of FLAMOD drug substance and drug product have been developed and validated. Furthermore, the Fill and Finish of FLAMOD is completed, and FLAMOD has been analysed at SSI. The preparation of the investigational medicinal product dossier is going well, and SSI expects to finalise it ahead of the Clinical Trial Application by the clinical team.
    Charlotte Green-Jensen
    Charlotte Green-Jensen
    Lina Saem Stoy
    Lina Saem Stoy
    Grith Kroyer Wood
    Grith Kroyer Wood
    Peter Bang
    Peter Bang
    Ann Fich Holmbjerg
    Ann Fich Holmbjerg
    Rikke Soe
    Rikke Soe
    Pia Helen Damm
    Pia Helen Damm
    The first toxicology studies on preclinical models of human primary airway epithelium have been conducted.
    Samuel Constant
    Samuel Constant
    Rosy Bonfante
    Rosy Bonfante
    Jimmy Vernaz
    Jimmy Vernaz
    The hypothesis of boosting antibiotic therapy with FLAMOD has been consolidated in preclinical models of bacterial pneumonia.
    Christophe Carnoy
    Christophe Carnoy
    Mara Baldry
    Mara Baldry
    Christine van Linge
    Christine van Linge
    Adeline Sezard
    Adeline Sezard
    The framework for modelling the PK/PD and the dose of FLAMOD is setup and will be run for toxicology and clinical studies.
    Charlotte Kloft
    Charlotte Kloft
    Sarah Zohar
    Sarah Zohar
    Sandrine Boulet
    Sandrine Boulet
    Emmanuelle Comets
    Emmanuelle Comets
    Moreno Ursino
    Moreno Ursino
    A retro planning agenda and fruitful interactions between sponsor, investigator, and partners have been developed for the phase 1 clinical trial.
    Hélène Espérou
    Hélène Espérou
    Benjamin Hamzé
    Benjamin Hamzé
    Antoine Guillon
    Antoine Guillon
    Cohorts of pneumonia patients have started to be included for stratification purposes.
    Tom van der Poll
    Tom van der Poll
    Erik Michels
    Erik Michels
    Justin de Brabander
    Justin de Brabander
    Acceptability of nebulized FLAMOD has started to be studied in online surveys and focus groups.
    Delphine Grynberg
    Delphine Grynberg
    Valérie Vaccaro
    Valérie Vaccaro
    The mapping review for the economic model has been generated and the systematic review is ready to start.
    Jo Picot
    Jo Picot
    Lorna Hazell
    Lorna Hazell
    Lois Woods
    Lois Woods
    Joanne Lord
    Joanne Lord
    Up to now, ethical evaluation of the whole project has been successfully approved by EU thanks to the interest and respect of all partners and the excellent management of the project by the Project Management Team.
    Florence Chung
    Florence Chung
    Antoine Campagne
    Antoine Campagne

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