The aim of this project is to generate preclinical evidence in preparation for clinical trials, to rapidly bring to market a simple but effective therapeutic approach for the treatment of bacterial pneumonia: BELOPENEM. This therapeutic approach is based on a novel drug delivery system BeloGal that selectively directs the broad spectrum antibiotic meropenem to the infected lungs of hospitalized pneumonia patients. Upon completion of the project, BELOPENEM will be ready for clinical development.
The consortium will perform formulation studies, followed by in vitro and in vivo efficacy studies, manufacturing and regulatory studies. Reformulating a well-known, approved drug, has the additional advantage of a shorter EMA and FDA approval routes (EMA/CHMP/351889/2013: i.e. enhanced EMA-PRIME eligibility).
Meropenem is worldwide clinically recognized antibiotic used for treatment of pneumonia. Meropenem is an off-patent broad spectrum carbapenem which since 1996 has been approved for most types of gram-negative, and -positive infections. The drug is intravenously administered and is listed as essential drug by the WHO. Meropenem has been used in other commercial reformulations but never targeted to the site of infection.