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Mpex Pharmaceuticals Presents Positive Phase 2 Clinical Trial Results of Aeroquin(TM) (MP-376) Treatment in Cystic Fibrosis Patients
Date:5/17/2010

>The trial met the primary endpoint of a reduction in sputum Pseudomonas aeruginosa density at Day 28, the end of treatment.  All three doses of Aeroquin demonstrated statistical significance (p < 0.01 for each group versus placebo), with the highest dose (240 mg BID) showing the greatest effect of approximately 1 log reduction.  There was no evidence for emergence of bacterial resistance during the study.

Improvements in respiratory function were also demonstrated in the trial.  A greater proportion of patients had improvement in percent predicted FEV1 with any dose of Aeroquin compared to placebo, with a difference of 10.9% in percent predicted FEV1 between the 240mg BID group and placebo at day 28 (p=0.0008).  Patients treated with 240 mg BID also had a 22% improvement in FEF25-75 (p<0.0001) and a 7.3% improvement in percent predicted FVC (p=0.014) at day 28 versus placebo.  FEV1, FEF25-75 and FVC are standard measures of lung function in CF patients.

Consistent with these results, a statistically significant reduction in the need for other inhaled and/or systemic anti-pseudomonal antimicrobials was observed in all Aeroquin groups vs. placebo (risk reduction of 79% for 240mg BID vs. placebo; p=0.0007). The percent of patients with adverse events (AEs) was similar across all treatment groups, with no evidence of increasing incidence or severity of AEs with increasing Aeroquin dose.

"The results from the Aeroquin Phase 2b CF trial are very encouraging both in terms of the improvement in lung function and the reduction in the need for other anti-pseudomonal antimicrobials," stated Dr. Conrad. "The combination of these outcomes with an attractive safety profile to date and a convenient dosing regimen makes Aeroquin a potentially important new agent.  These results were especially impressive because they were obtained in a
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SOURCE Mpex Pharmaceuticals, Inc.
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