FDA Grants KaloBios Pharmaceuticals Orphan Drug Designation for KB001-A

KaloBios Pharmaceuticals, reported that FDA has granted the company orphan drug designation for KB001-A, an anti-PcrV monoclonal antibody (mAb) fragment, for the treatment of cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa). KaloBios is currently enrolling patients in a Phase II clinical trial with KB001-A in CF patients chronically infected with Pa. This 180-patient study is intended to evaluate the efficacy and safety of repeat doses of KB001-A. The primary endpoint is time-to-need for antibiotics.

Source: KaloBios Pharmaceuticals