Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA
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.
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
(200mg bid)Vancocin® capsules
(125mg qid)p-value95% Confidence IntervalClinical Cure 91.9% (442/481 patients)
90.2% (467/518 patients)
(-1.8, 5.3)Recurrence13.0% (51/391)
(-16.8, -6.1)Global Cure78.6% (378/481)