Phase 2b study of Aeroquin for treatment of cystic fibrosis (CF)

Mpex Pharmaceuticals announced positive data from its Phase 2b clinical trial with Aeroquin (levofloxacin aerosol), also known as MP-36, for the maintenance treatment of bacterial infections associated with cystic fibrosis (CF). This international, multi-center randomized, double-blind, placebo-controlled trial studied 151 CF patients to evaluate the safety, tolerability and efficacy of inhaled Aeroquin administered for 28 days using an Investigational eFlow Nebulizer System (PARI Pharma GmbH). Trial results showed that nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa (P. aeruginosa) in sputum after 28 days of dosing versus placebo. Clinically and statistically significant improvements versus placebo were also seen in a number of important clinical endpoints, including FEV1, percent predicted FEV1, FEF25-75 (all measures of respiratory function) and time to need for anti-pseudomonal antibiotics (a measure of exacerbations). Both once and twice-daily dosing of Aeroquin showed activity in this trial, with higher doses showing improved responses.

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.

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