SAN DIEGO, May 17 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today announced the presentation of data from its Phase 2b clinical trial with Aeroquin™ (a proprietary aerosol formulation of levofloxacin, MP-376) in cystic fibrosis (CF) at the American Thoracic Society (ATS) Annual Meeting in New Orleans. Trial results demonstrated statistically significant improvements in bacterial load, respiratory function and time to need for anti-pseudomonal antibiotics (a measure of exacerbations) versus placebo in a heavily treated patient population. The results were presented by Dr. Douglas Conrad from the University of California at San Diego School of Medicine, the principal investigator for the study.
The Phase 2b, multi-center randomized, double-blind, placebo-controlled trial (Mpex 204) studied 151 CF patients to evaluate the safety, tolerability and efficacy of three dose levels of inhaled Aeroquin (120mg QD, 240 mg QD and 240 mg BID) administered for 28 days using an customized investigational eFlow® Nebulizer System (PARI Pharma GmbH). Patients were then followed for an additional 28 days after completion of dosing. The trial was conducted in the U.S., Germany and the Netherlands.
To ensure that results from this trial were as predictive as possible for the future Phase 3 program and consistent with current clinical practice, the study enrolled patients that had recently received multiple courses of inhaled antibiotics and in most cases were receiving concomitant medication such as dornase alpha, azithromycin and hypertonic saline that have been shown in previous studies to improve lung function and/or reduce exacerbations.