SAN DIEGO, Oct. 23 /PRNewswire/ — Optimer Pharmaceuticals, Inc.
(Nasdaq:
OPTR) announced today the presentation of combined data from
its two fidaxomicin Phase 3 trials in patients with Clostridium
difficile infection (CDI) at the 48th Annual Meeting of the
Infectious Disease Society of America (IDSA) in Vancouver, British
Columbia, Canada. During an oral presentation, investigator
Derrick Crook, M.D., of the University of Oxford, presented
combined data showing that CDI patients treated with fidaxomicin
experienced 47% fewer recurrences than patients treated with
vancomycin.
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Dr. Crook presented combined data from the two Phase 3 trials
showing cure rates, recurrence rates and global cure rates for the
intent to treat (ITT) population. The recurrence rates were
13% for the fidaxomicin arm compared to 24% for the vancomycin arm
(p < 0.001). Global cure rates were 75% for fidaxomicin compared
to 63% for vancomycin (p < 0.001). Cure rates were similar for
both fidaxomicin and vancomycin (88% vs. 86%). Fidaxomicin
was well-tolerated in both studies.
The combined results for the per protocol and modified intent to
treat populations are shown in the table below: Per
Protocol
(microbiologically evaluable)Fidaxomicin
(200mg bid)Vancocin® capsules
(125mg qid)p-value95% Confidence IntervalClinical Cure 91.9%
(442/481 patients)
90.2% (467/518 patients)
NA
(-1.8, 5.3)Recurrence13.0% (51/391)
24.6% (99/403)
< 0.001
(-16.8, -6.1)Global Cure78.6% (378/481)
66.4% (34
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