KaloBios KB001-A fails Phase 2 study and discontinues development of KB001-A in cystic fibrosis

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced top-line data from the randomized, double-blind, placebo-controlled Phase 2 study of KB001-A, an anti-PcrV monoclonal antibody (mAb) fragment, to treat Pseudomonas aeruginosa (Pa) lung infections in subjects with cystic fibrosis (CF). While the data from this … Continued

U.S. FDA Grants Orphan Drug Designation for KaloBios’ KB001-A in Treatment of Cystic Fibrosis Patients

KaloBios Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration (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 withPseudomonas aeruginosa (Pa). KaloBios is currently … Continued

KaloBios Initiates Phase 2 Study with KB001-A Humaneered Monoclonal Antibody in Cystic Fibrosis Patients

KaloBios Pharmaceuticals, Inc. today announced that dosing has begun in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of KB001-A, the company’s anti-PcrV Humaneered®, PEGylated monoclonal antibody fragment. The study will investigate the safety and efficacy of intravenously administered KB001-A … Continued