Mpex Reports Positive Data from Phase IIb CF Trial

Mpex Pharmaceuticals, a biopharmaceutical company, has reported positive data from its Phase IIb clinical trial with Aeroquin, a novel aerosol formulation of levofloxacin, MP-376 in cystic fibrosis.

According to Mpex Pharmaceuticals, trial results showed that nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa in sputum after 28 days of dosing versus placebo. Clinically and statistically significant improvements compared to placebo were also seen in a number of important clinical endpoints, including FEV1, percent predicted FEV1, FEF25-75 and time to need for anti-pseudomonal antibiotics. Both once and twice-daily dosing of Aeroquin showed activity in this trial, with higher doses showing improved responses. Aeroquin was well tolerated and no significant change in antibiotic resistance was observed in this study, the company said.

The Phase IIb, multi-center randomized, double-blind, placebo-controlled trial (Mpex 204) studied 151 cystic fibrosis patients to evaluate the safety, tolerability and efficacy of inhaled Aeroquin administered for 28 days using an investigational eFlow nebulizer system. Patients were then followed for an additional 28 days after completion of dosing. The trial was conducted in the US, Germany and the Netherlands.

Daniel Burgess, President and CEO of Mpex, said: “We thank the participating CF patients and physicians for helping make this trial a success. 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 III development.”
Mpex Pharmaceuticals, a biopharmaceutical company, has reported positive data from its Phase IIb clinical trial with Aeroquin, a novel aerosol formulation of levofloxacin, MP-376 in cystic fibrosis.

According to Mpex Pharmaceuticals, trial results showed that nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa in sputum after 28 days of dosing versus placebo. Clinically and statistically significant improvements compared to placebo were also seen in a number of important clinical endpoints, including FEV1, percent predicted FEV1, FEF25-75 and time to need for anti-pseudomonal antibiotics. Both once and twice-daily dosing of Aeroquin showed activity in this trial, with higher doses showing improved responses. Aeroquin was well tolerated and no significant change in antibiotic resistance was observed in this study, the company said.

The Phase IIb, multi-center randomized, double-blind, placebo-controlled trial (Mpex 204) studied 151 cystic fibrosis patients to evaluate the safety, tolerability and efficacy of inhaled Aeroquin administered for 28 days using an investigational eFlow nebulizer system. Patients were then followed for an additional 28 days after completion of dosing. The trial was conducted in the US, Germany and the Netherlands.

Daniel Burgess, President and CEO of Mpex, said: “We thank the participating CF patients and physicians for helping make this trial a success. 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 III development.”

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