Investigational KB001A Granted Fast Track for Pseudomonas aeruginosa
Sanofi Pasteur and KaloBios Pharmaceuticals announced that the FDA has granted Fast Track designation to Sanofi Pasteur for the investigation of KB001A, an antibody fragment, intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa in mechanically-ventilated patients.
KB001A, a Humaneered antibody fragment, is designed to fight P. aeruginosa by blocking a virulence mechanism (the Type Three Secretion System or TTSS) on the bacterium's external surface. By blocking P. aeruginosa's killing mechanism, KB001A is intended to reduce the damage done to the lungs by P. aeruginosa and potentially enable the patient's own immune system to effectively fight and clear the bacteria from sites of infection.
Sanofi Pasteur is currently conducting a Phase 1 trial of KB001A in the U.S. and has started the planning of a Phase 2b study. KaloBios is currently conducting a 180-patient Phase 2 study in cystic fibrosis in the U.S. with KB001A. KB001, a precursor, has completed two clinical studies in mechanically ventilated patients colonized with P. aeruginosa and in chronically P. aeruginosa infected patients with cystic fibrosis.