BioCentury
ARTICLE | Clinical News

VP20621: Phase II data

April 29, 2013 7:00 AM UTC

A double-blind, international Phase II trial in 168 patients previously treated for CDI with oral vancomycin or metronidazole showed that all doses of once-daily VP20621 met the primary endpoint of increasing the proportion of patients with non-toxigenic C. difficile detected in stool during the 14-day treatment period vs. placebo. Specifically, non-toxigenic C. difficile was detected in stool culture in 54% of patients receiving 104 spores of VP20621 for 7 days (followed by placebo for 7 days), 79% of patients receiving 107 spores of VP20621 for 7 days (followed by placebo for 7 days) and 73% of patients receiving 107 spores of VP20621 for 14 days vs. 0% for placebo (p<0.0001 for all). On secondary endpoints, 107 spores of VP20621 for 7 days significantly reduced the incidence of CDI recurrence at week 6, defined as >=3 unformed stools within 24 hours, positive C. difficile stool assay and no other likely cause of diarrhea occurring after day 1 through week 6, vs. placebo (5% vs. 30%, p<0.01). VP20621 non-significantly reduced the incidence of CDI recurrence at week 6 in the 104 spores for 7 days dose group (15%, p=0.11) and the 107 spores for 14 days dose group (15%, p=0.1). ...