The anti-Pseudomonas aeruginosa (Pa) type III secretion system (TTSS) antibody KB001-A may be a non-antibiotic strategy to reduce airway inflammation and damage in CF patients with chronic Pa infection, according to results of the initial single-dose Phase 1 clinical study of KB001-A .
“Many patients with CF are chronically infected with Pa which contributes to disease progression by causing a strong inflammatory response that destroys lung tissue,” said Nestor A. Molfino, MD, MSc, chief medical officer for KaloBios. “Treating Pa infection with antibiotics has long been shown to benefit CF patients; however, Pa is not eradicated by such treatments and antibiotic-resistant strains soon emerge.
Phase I showed a single intravenous dose of KB001 to have an acceptable safety profile and a trend toward a short-term reduction in markers of inflammation, particularly neutrophil elastase, which has long been recognized as the main enzyme responsible for lung damage in CF patients, according to researchers.
The published study results showed a single intravenous dose of KB001; investigators noted the need for repeat-dosing studies to determine the durability of the anti-inflammatory effects and how treatment with KB001 might translate into clinical benefit.
KaloBios is currently recruiting for a 180-patient study to evaluate the efficacy and safety of repeat doses of KB001-A. The Phase 2 study is a multi-dose, randomized, double-blind, placebo-controlled clinical trial with KB001-A in CF patients chronically infected with Pa.