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Treatment With VP20621 (Non-Toxigenic Clostridium difficile; NTCD) In A Phase 2 Study Resulted In High Rates Of Colonization And Statistically Significant Reductions In Recurrence Of C. difficile Infection
Date:4/22/2013

sceptible individuals with a non-toxin-producing strain of C. difficile appears to prevent infection by a toxic, virulent strain and these data support that observation. The results of the study provide insight into how colonization rates may be increased further, for example, by starting VP20621 dosing earlier and using the optimum dosing regimen in confirmatory studies powered to show a difference in recurrence rates. These are very exciting data, and offer clinicians and patients hope that a preventive therapy for recurrent CDI may one day be available to them."

About the Phase 2 study
The Phase 2 randomized, double-blind study was designed to determine the tolerability of VP20621 dosed orally for up to 14 days in adults previously treated for CDI with oral vancomycin or metronidazole. After completing the antibiotic treatment, subjects were given either placebo (n=43), or VP20621 doses of 104 spores QD (once per day) for 7 days (n=41), 107 spores QD for 7 days (n=43), or 107 spores QD for 14 days (n=41).  The overall median age of study subjects was 59 years; 39 percent were >/= 65 years old; 62 percent were female. Data from the study are shown below: 

Microbiology and Clinical endpoints:
Study drug was to be administered to all subjects for 14 days to maintain the blind.  Data below pertain to the 6 weeks following the first dose of study drug, which defined the period for evaluation of CDI recurrence. Colonization was determined by microbiological culture of stool and CDI recurrence was defined as >/= 3 unformed stools within 24 hours, positive C. difficile stool assay and no other likely cause of diarrhea occurring after day one through week 6.

Detection of NTCD in stool and rates of CDI recurrence, Antibacterial Use for CDI Treatment and Clinical Diarrhea Events; Placebo vs. VP20621Placebo

VP20621104 x 7d

107 x 7d


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SOURCE ViroPharma Incorporated
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