Breathing new in severe lung diseases: innovative therapeutic approaches based on inhalable formulations

The general aim of the BREATHE project is the integrated development of pulmonary delivery strategies useful to improve the efficacy of innovative oligonucleotide (ON)-based therapies for severe lung diseases, with a special emphasis to double stranded ONs. Upon positive peer-review of the European Science Foundation, the Italian Foundation Compagnia di San Paolothrough the so-called STAR program (i.e., Territorial Support to Research Activity) funded the Start-up phase of the project. it is a 2-year joint project involving Italian research teams from Dept. of Pharmacy of University of Naples Federico II (UNINA), Second University of Naples (SUN), National Cancer Institute of Naples G. Pascale (NCI), Giannina Gaslini Institute of Genoa (GASLINI) and a research team from Université Catholique de Louvain, Belgium (UNILV). The project is organized in 2 main work packages (WP), each characterized by specific objectives. In the context of each WP, the activities will be carried out in three steps, i.e. design and production of engineered dry powders (T1), evaluation of biological behavior and in vitro effects on cells of the dry powder formulations (T2), evaluation of in vivo biodistribution, toxicity and activity on rat models (T3). In particular, the feasibility of dry powders for inhalation of decoy ONs and siRNA, one of groundbreaking advances in pulmonary delivery over the past 30 years, will be investigate in different preclinical models.