Dosing has begun in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of KB001-A, the anti-PcrV, PEGylated monoclonal antibody fragment from biopharmaceutical company KaloBios Pharmaceuticals Inc.
The study will investigate the safety and efficacy of intravenously administered KB001-A as a treatment for chronic Pseudomonas aeruginosa (Pa) infection in cystic fibrosis patients.
“Cystic fibrosis patients are subject to chronic lung infections with Pa, a gram negative bacteria which is a leading contributor to the deterioration of pulmonary function leading to respiratory failure,” said Nestor A. Molfino, M.D., KaloBios’ Chief Medical Officer.
“The only currently approved treatments for Pa infections are antibiotics, but despite their therapeutic benefit, mortality and morbidity remain high due to Pa antibiotic resistance. KB001-A is designed to neutralize Pa pathogenicity, which reduces inflammation and allows the body’s natural immune system to kill and clear the bacteria. As a result, we believe KB001-A may offer a novel approach to preventing and treating Pa infections when added to antibiotics, and may not be subject to the typical drug resistance mechanisms.”
The company plans to use data from this Phase 2 study of intravenous KB001-A, if positive, to support pivotal trials of a subcutaneous formulation of KB001-A.