"The results of this study are very gratifying, particularly given the heavily treated nature of the patients included in this trial," stated Dr. Jeff Loutit, Chief Medical Officer of Mpex Pharmaceuticals. "It is difficult for new agents to show benefit on top of state-of-the-art care in CF, and generating statistically significant results across a broad range of key endpoints in this Phase 2b study bodes well for success in Phase 3."
"We thank the participating CF patients and physicians for helping make this trial a success," stated Daniel Burgess, President and CEO of Mpex Pharmaceuticals. "We are eager to meet with CF experts and regulatory authorities in the U.S. and Europe to discuss these results and determine the most expeditious path to move Aeroquin through Phase 3 development."
Patients with CF suffer from chronic infections of the lower respiratory tract that can be caused by multiple bacteria, including P. aeruginosa. Chronic pulmonary infection is associated with a decrease in lung function over time caused by inflammation arising from bacteria and their toxins. Periodic exacerbations in the lung result from bacterial overgrowth, and these exacerbations are implicated as a major cause of morbidity and mortality in CF patients.
About Aeroquin (MP-376)
MP-376 is a proprietary formulation of levofloxacin that has been optimized for aerosol delivery using a customized Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH). Levofloxacin is a fluoroquinolone antibiotic that has been widely used in a variety of indications for over a decade and has established safety and efficacy when administered orally or intravenously against many bacterial pathogens, including P. aeruginosa. Administration of MP-376 with a high efficiency nebulizer to th
|SOURCE Mpex Pharmaceuticals, Inc.|
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