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Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection
Date:5/17/2009

egion and professor in the Departments of Medicine and Microbiology-Infectious Diseases, University of Calgary. "These findings indicate that fidaxomicin offers both highly effective but more selective therapy that is less damaging to the normal intestinal bacteria that protect against recurrence of CDI."

Additional findings also presented for the first time include a subgroup analysis of clinical cure and recurrence rates for fidaxomicin compared to Vancocin, as well as baseline demographic and disease characteristics. Clinical cure rates for fidaxomicin and Vancocin were similar in each of the following subgroups: patient status (in-patient/out-patient), age (under/over 65) and strain type (BI/NAP1/027). Most notably, fidaxomicin showed a reduction across several subgroups in recurrence rates compared to Vancocin in both out-patient and in-patient settings, as well as in patients both over and under the age of 65. The recurrence rates in the BI/NAP1/027 subgroup were similar between fidaxomicin and Vancocin.

    Per Protocol                          Fidaxomicin     Vancocin(R) capsules
    (microbiologically evaluable)         (200mg bid)         (125mg qid)

    Recurrence Rates by Subgroup
    Patient Status
      In-patient                          17.9% (19/106)      26.1% (29/111)
      Out-patient                          8.6% (9/105)       21.8% (24/110)

    Age
      < 65                                 9.5% (12/126)      18.6% (22/118)
      >/= 65                              18.8% (16/85)       30.1% (31/103)

    Strain Type
     BI (NAP1/027)                        25.0% (11/44)       24.1% (13/54)
    Overall                               13.3% (28/211)      24.0% (53/221)

Baseline demographic and disease characteristics of study participants were similar between the fidaxomicin and Vancocin arms. The BI/NAP1/027 hyper virulent strain of C. difficile'/>"/>

SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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