Phase 2a trial results with KB001 suggest the recombinant, human
PEGylated monoclonal antibody fragment, under development by KaloBios
Pharmaceuticals, Inc. and Sanofi Pasteur, offers potential as an
alternative to antibiotics for preventing or reducing pneumonias in
mechanically ventilated intensive care unit (ICU) patients heavily
colonized with Pseudomonas aeruginosa (Pa).
Results of the Phase 2a study, sponsored in its entirety by KaloBios and
conducted at 10 ICUs across France, have been published online
and will appear in the August issue of Critical Care Medicine.
The study conducted from April 2008 to July 2009 found no clinically
significant differences in safety between the KB001 treated patients and
those treated with only standard of care. In addition, the study showed
KB001 to be well tolerated and non-immunogenic, and have favorable
pharmacokinetics and predictable dose-dependent penetration into the
lungs of ICU patients heavily colonized with Pa. While the
39-patient randomized, placebo-controlled, double-blind study was
insufficiently powered to show statistical significance related to
efficacy, patients receiving intravenous infusions of KB001 tended to
have better clinical outcomes. Investigators reported that 33.3% of the
3 mg/kg>Pa infection free, versus only 20% of the placebo
(n = 10) group.
"Based on these results, KB001 shows promising potential for reducing Pa
pneumonia incidence in mechanically ventilated ICU patients colonized
with Pa bacterium," said Néstor Molfino, Chief Medical Officer of
KaloBios. "Our partner Sanofi Pasteur is planning to pursue this
approach in larger clinical trials, while we will continue development
in treating cystic fibrosis patients with chronic Pa."
An Alternative Approach to Antibiotics