The main achievements of the FAIR project to date are summarized below:
• An efficient coordination and management of the project, a successful organisation of regular meetings of the governing bodies, a practical and secured plan for data management, and a well-targeted communication and dissemination (
https://fair-flagellin.eu(si apre in una nuova finestra)) including the organization of a webinar and preparatory work for a course on nebulized drugs for the next reporting period, have been produced.
• The production and release of flagellin/FLAMOD Drug Product for the phase 1 clinical trial have been completed and the stability program studies are ongoing. The regulatory toxicology studies as well as the Investigational Medicinal Product Dossier (IMPD) have been completed and provided to the phase 1 clinical trial Sponsor for the regulatory submission of the Clinical Trial Application (CTA) package.
• Mathematical modelling and simulation approaches have been applied to integrate published knowledge and experimental data from in vitro and preclinical FAIR investigations. These models have provided valuable insights into the pharmacokinetics of FLAMOD, in the body, and its pharmacodynamics, including its effects on the innate immune system. Preclinical investigations have further defined the potency of inhaled FLAMOD as an adjunct therapy to standard-of-care antibiotics in treating respiratory tract infections. This data-driven approach has been critical in determining the optimal lung-targeted dose and potential systemic exposure in humans, informing the dosing and design of the Phase 1 clinical trial.
• Significant progress has been made in preparing the Phase 1 clinical trial approval package. By the end of this reporting period, the package was nearing completion, with plans to submit it to regulatory authorities in Q3 of 2024. The clinical trial is expected to commence in Q4 of 2024, marking a pivotal step towards evaluating the safety and biological activity of FLAMOD in healthy individuals.
• Advances in biomarker discovery have led to the identification and validation of several markers from two patient cohorts, which have been corroborated in independent cohorts. These biomarkers are crucial in stratifying patients with severe pneumonia, enabling the identification of those who are most likely to benefit from flagellin/FLAMOD aerosol therapy.
• To assess the future acceptability of FLAMOD among patients and clinicians, comprehensive surveys and interviews were conducted and finalized. The findings indicate that the proposed/future procedure to administrate the nebulized FLAMOD, used as an adjunct to antibiotic treatment, is well-accepted by both clinicians and patients.
• A systematic, evidence-based review has been conducted to evaluate the effectiveness of current pneumonia treatments. This review will inform the development of an economic decision model, which will be used to estimate the healthcare economics and potential benefits of treatments involving nebulized FLAMOD.
• Throughout the project, ethics requirements have been continuously monitored and reported by FAIR’s Independent Ethics Advisor.
