Study met its primary endpoint
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Mpex Pharmaceuticals (Mpex) has reported positive data from its phase 2b clinical trial with Aeroquin (a novel aerosol formulation of levofloxacin, MP-376) in cystic fibrosis (CF).
Reportedly, the 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, as compared to placebo.
The company stated that clinically and 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.
In addition, both once and twice-daily dosing of Aeroquin, showed activity in the trial, with higher doses showing improved responses. Aeroquin was well tolerated and no significant change in antibiotic resistance was observed in this study, claims the company.
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