Study Results

• What We Learned:

  Study results show that there was a significant reduction in Pseudomonas aeruginosa density in the treatment group compared to the placebo group. Additionally, the occurrence of adverse events was similar across all treatment groups.

• Primary Findings:

  Effectiveness:

  This study was conducted between June 2008 and June 2009. The study enrolled 151 CF patients and 143 completed the study. The trial met the primary endpoint of a reduction in sputum Pseudomonas aeruginosa density at Day 28, the end of treatment. All three dose levels of MP-376 demonstrated statistically significant reduction in P. aeruginosa with the highest dose (240 mg twice a day) showing the greatest effect of approximately 1 log reduction.

   

  Statistically significant improvements in respiratory function and reduction in the need for other antibiotics were also demonstrated in the trial.

  Safety:

  The percent of patients with adverse events (AEs) was similar across all treatment groups, with no evidence of increasing incidence or severity of AEs with increasing MP-376 doses.

• Citation:

  Am J Respir Crit Care Med 2011;183(11):1510-1516

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