ViroPharma Inc. (VPHM) reported Phase 2 study results of VP20621, a novel treatment approach for preventing recurrent C. difficile infections or CDI. CDI is a 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, VP20621 was well tolerated, with mild-moderate headache the only notable associated adverse event reported by 10 percent of subjects, versus 2 percent on placebo. According to the company, Viable non-toxigenic C. difficile was detected in stool culture in 54 percent of subjects treated with the low dose of VP20621 and up to 79 percent of those receiving the high dose. Further, across all dose groups, VP20621 reduced the incidence of CDI recurrence by greater than or equal to 50 percent versus placebo, with a similar reduction in antibacterial treatment for CDI vs. placebo in this trial.
ViroPharma's chief scientific officer stated, "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."
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