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news.Optimer Pharmaceuticals has announced positive results from its first double-blind Phase III trial assessing the safety and efficacy of Prulifloxacin as a once-daily, three-day oral therapy for infectious diarrhea.
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The top-line analysis of data from this study shows that Prulifloxacin met the primary endpoint of time to last unformed stool (TLUS) in both the mITT (modified intent-to-treat; n=187) and microbiologically evaluable (per protocol; n=165) populations compared to placebo.
The median TLUS for patients treated with Prulifloxacin was approximately 24 hours; this was significantly different from the TLUS for placebo with a p-value of <0.0001. Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo. Michael Chang, president and CEO of Optimer, said: "We are encouraged by the positive data, which shows superiority of Prulifloxacin over placebo. We believe these results provide a solid foundation for pursuing a new drug application with the FDA, assuming similar data from a second Phase III trial."