EXTON, Pa., April 22, 2013 /PRNewswire/ -- ViroPharma Incorporated (VPHM), an international biopharmaceutical company committed to developing and commercializing innovative products that address unmet medical needs and rare diseases, today announced the results of a Phase 2 study of VP20621 (non-toxigenic Clostridium difficile; NTCD) a novel treatment approach for preventing recurrent C. difficile infections (CDI). CDI is a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications. VP20621 contains the spores of a naturally occurring non-toxin producing strain of C. difficile.
In this study of 168 patients who were randomized and dosed following antibiotic treatment for CDI, VP20621 was well tolerated, with mild-moderate headache the only notable associated adverse event reported by 10 percent of subjects compared to 2 percent on placebo. Viable non-toxigenic C. difficile was detected in stool culture (the primary endpoint of the study) in 54 percent of subjects treated with the low dose of VP20621 and up to 79 percent of those receiving the high dose. In addition, across all dose groups, VP20621 reduced the incidence of CDI recurrence (a secondary endpoint of the study) by greater than or equal to 50 percent vs. placebo, with a similar reduction in antibacterial treatment for CDI vs. placebo in this study. The CDI recurrence rate was two percent (2/86) in the subgroup of patients successfully colonized with VP20621.
"These data demonstrate that colonization with VP20621 was achieved in the majority of patients, and that in these patients, 98 percent had no recurrence of C. difficile infection," commented Dr. Colin Broom, ViroPharma's chief scientific officer. "We have long known that colonization of susceptible 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 studyThe 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. VP20621
Placebo
VP20621
104x 7d
107x 7d
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Treatment With VP20621 (Non-Toxigenic Clostridium difficile; NTCD) In A Phase 2 Study Resulted In High Rates Of ...