MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory
tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which
has been particularly problematic to eradicate and been implicated as the major cause of
morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung
increases the local concentrations of antibiotic at the site of infection resulting in
improved antimicrobial effects compared to systemic administration. Decreased efficacy,
intolerance and high treatment burden with currently available therapies indicate a need for
additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone
levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies
conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an
antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal
antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active
against CF pathogens including those with high minimum inhibitory concentration (MIC) levels
to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled
MP-376 can be delivered rapidly and efficiently using a customized PARI investigational
configuration of the eFlow® nebulizer system.