Study Results

• What We Learned:

  Study results show that both the high and low doses of KB001 resulted in a significant reduction in sputum neutrophil activity (a marker of airway inflammation) compared to the placebo group. Additionally, there were no safety concerns associated with KB001 treatment.

• Primary Findings:

  Effectiveness:

  This multi-center study was conducted between March 2008 and May 2009. A total of 27 people with CF, age 12 years and older and with chronic Pseudomonas aeruginosa infection were enrolled and randomized to receive a single dose of either 3mg/kg or 10mg/kg of the anti-pseudomonal antibody fragment, KB001, or placebo.

   

  A significant overall reduction in sputum neutrophil elastase and neutrophil counts were seen in both of the KB001 dose groups vs. placebo. The KB001 mean serum half-life was 11.9 days. No significant differences between treatment groups were seen in pulmonary function, symptoms, or sputum Pseudomonas aeruginosa density after a single dose.

  Safety:

  The safety, pharmacokinetic (PK), and pharmacodynamic (PD) properties of KB001 were assessed. Both the high and low doses were well tolerated. No subject developed anti-KB001 antibodies.

• Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.