The multinational Phase II clinical trial, with an enrollment of 265 patients in three arms, showed nemonoxacin 750mg once daily in an oral dose over a period of seven days achieved non-inferiority in clinical cure rate of community-acquired pneumonia (CAP) compared with levofloxacin 500mg once daily in this double-blinded study.
Overall, 82.6% of the intent-to-treat population and 90% of the evaluable population were cured with nemonoxacin compared with 80.0% and 91% cure rate in the levofloxacin arm. Nemonoxacin has demonstrated safety results that were similar to those seen with levofloxacin and were consistent with the favorable safety profile observed with nemonoxacin in earlier Phase Ia and Phase Ib trials.
Ming-Chu Hsu, chairman and CEO of TaiGen, said: “TaiGen’s second Phase II trial in diabetes-foot infection is designed to demonstrate nemonoxacin’s anti-MRSA activity with oral dosing. A once-a-day IV dosing is scheduled to enter clinical trial second quarter of 2008.”