ViroPharma Inc. (VPHM) Monday said a Phase 2 study has revealed that treatment using VP20621 reduced recurrent Clostridium difficile infections or CDI by greater than or equal to 50 percent versus placebo, with a similar reduction in antibacterial treatment for CDI versus placebo in this trial.
Use of VP20621 or non-toxigenic Clostridium difficile is a novel treatment approach for preventing recurrent CDI, which is a dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications. According to the firm, VP20621 contains spores of a naturally occurring non-toxin producing strain of C. difficile.
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.
The study was conducted in 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, the company noted.
"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," said Colin Broom, chief scientific officer.
ViroPharma acquired VP20621 in 2006, through a licensing agreement with Dale Gerding, professor of Medicine at Loyola University Chicago. The company said it will complete the evaluation of these Phase 2 data which will help determine a future development pathway.
VPHM is currently trading at $25.9, down 0.42 percent.
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