Improved Pneumonia Treatment Through Targeted Drug Delivery
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.
The key innovation elements of BELOPENEM are:
Targets the growing, global need of antibiotic resistance
Increased efficacy due to increased local drug concentration
Reduced side effects due to reduced systemic drug concentration
Broad spectrum application to both gram-positive and -negative bacteria
First commercial use of a targeted drug delivery formulation to combat bacterial pneumonia
A giant spin-off application of efficient local drug delivery technology to lung (i.e. for cancer, Cystic fibrosis, COPD, tuberculosis)