Mpex initiates Phase Ib cystic fibrosis drug trial

MP-376 is a proprietary aerosolized formulation of the antibiotic levofloxacin that is being developed for the treatment of chronic lung infections due to pseudomonas aeruginosa in CF patients.

Mpex says preclinical and early clinical studies indicate that active levofloxacin concentrations in pulmonary tissues after MP-376 administration are markedly increased compared to those achieved when the antibiotic is delivered by other routes of administration.

The trial is being conducted under an open investigational new drug application that has been filed with the FDA.

The current clinical trial is a randomized, placebo-controlled, multi-center study in the US that will evaluate the safety, tolerability, pharmacokinetics, and microbiological effects of multiple daily doses of MP-376 in stable cystic fibrosis patients with chronic infections due to Pseudomonas aeruginosa. A total of 39 patients are planned to be enrolled, and several dose levels will be evaluated.

This study complements a single dose, dose escalation study of MP-376 that was recently completed in healthy volunteers and CF patients in Denmark. Together, the single and multiple dose trials are expected to support a larger Phase 2 study that the company plans to initiate in 2008.

“Based on our work to date, we believe MP-376 has the potential to provide doctors and patients with a convenient, powerful and well-tolerated new treatment option that addresses key pathogens in CF and minimizes the potential for drug resistance,” stated Dr Michael Dudley, senior vice president of research and development for Mpex.