KaloBios Pharmaceuticals Inc recently announced data on a Phase 2 randomized double-blind, placebo-controlled trial of KB001-A, an anti-PcrV monoclonal antibody (mAb) fragment, to be used as treatment for Pseudomonas aeruginosa (Pa) lung infections in subjects with cystic fibrosis (CF).
Results from the KaloBios KB001-A showed that the compound was safe with no major tolerance complications. However, the primary endpoint — indication of reduced risk to develop pulmonary exacerbations — was not met. The trial’s secondary endpoints included improvements in FEV1, and subject-reported outcomes (assessed with the Cystic Fibrosis Respiratory Symptom Diary). However, these secondary end-points did not reveal any advantage with the KB001-A, either.
