Mpex Pharmaceuticals announced the initiation of a Phase 3 trial program with Aeroquin (levofloxacin aerosol), also known as MP-36, for the maintenance treatment of bacterial infections associated with cystic fibrosis (CF). The first study in this program is a multi-center, international, randomized, double-blind, placebo-controlled trial (Mpex 207) that is expected to enroll approximately 300 stable CF patients to evaluate the safety, tolerability and efficacy of 240mg of Aeroquin administered twice daily using an optimized, Investigational eFlow Nebulizer System for 28 days. The primary efficacy endpoint to be assessed in the trial will be time to exacerbation. Additional endpoints include time to need for anti-pseudomonal antimicrobials, as well as change from baseline to Day 28 in lung function, the respiratory domain score of the CFQ-R and sputum Pseudomonas aeruginosa density. An additional Phase 3 trial comparing Aeroquin to Tobi (tobramycin inhalation solution, from Novartis) over three 28-day cycles (Mpex 209) is expected to begin enrolling patients in the next several weeks.
Aeroquin is a proprietary aerosol formulation of levofloxacin, a fluoroquinolone antibiotic with established safety and efficacy when administered orally or intravenously against many bacterial pathogens, including P. aeruginosa. Administration of Aeroquin with a high efficiency nebulizer to the lungs allows for the rapid delivery of high concentrations of active drug directly to the site of infection, while minimizing systemic exposure.
For more information call (858) 875-2840 or visit www.mpexpharma.com.