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Optimer Announces Presentation of Additional Data from Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection (CDI) Presented at ICAAC
Date:9/14/2010

nd vancomycin for intervening infections during the study.  The data indicated fidaxomicin was a superior therapy to vancomycin in preventing recurrence and in promoting global cure in patients requiring concomitant antibiotics.  The analysis from the Phase 3 trials indicated that in patients receiving concomitant antibiotics, those treated with fidaxomicin versus vancomycin had a significantly lower CDI recurrence rate (17% vs. 28%, p=0.039) and had a significantly improved global cure rate (73% vs. 60%, p=0.013).  At the same time, among subjects who received no concomitant antibiotics, recurrence in vancomycin-treated subjects was double that of fidaxomicin-treated subjects (23% vs. 11.5%, p<0.001).

Ellie J. Goldstein, M.D., from the R.M. Alden Research Laboratory in Santa Monica, CA, presented data on the antimicrobial susceptibilities of C. difficile isolates to fidaxomicin, vancomycin, metronidazole, and rifaximin cultured from fecal specimens collected from patients at study entry and at failure/recurrence in Optimer's second Phase 3 clinical trial. The data showed that there was no relationship between MICs of baseline CDI isolates and clinical outcome for fidaxomicin but there was a one dilution difference for vancomycin between cure and failure.  The MIC90s were generally low for fidaxomicin,  vancomycin, and metronidazole but the BI isolates generally had higher MICs for the four drugs tested than the BK, CF, DH, G, J, and Y group isolates. No resistance to either fidaxomicin or vancomycin developed during the 10-day treatment in this or in the first Phase 3 trial.  Rifaximin resistant strains, 8.1% of all strains, were isolated in both treatment groups with MIC90s higher in treatment failures than cures.

In an oral presentation, Dale N. Gerding, M.D., an investigator from the Hines VA Hospital in Chicago, IL, presented data on the C. difficile strain types isolated in Optimer's two fidaxomicin
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SOURCE Optimer Pharmaceuticals, Inc.
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