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ViroPharma Initiates Phase 2 Study of VP 20621 for Prevention of Recurrence of Clostridium difficile Infection (CDI)
Date:5/19/2011

rupt the normal gastrointestinal flora which renders individuals susceptible to C. difficile colonization.  Orally-dosed liquid VP 20621 utilizes non-toxigenic spore-based technology as a potential means of recolonization and protection. The goal of VP 20621 dosing following antibiotic exposure is to colonize with this non-toxigenic strain of C. difficile and to prevent colonization and infection with toxigenic strains, thereby preventing disease. VP 20621 may have therapeutic utility in the prevention of recurrence following treatment of acute CDI and in the primary prevention of CDI.  A Phase 1 escalating dose study included healthy subjects above 60 years of age who were pre-dosed with oral vancomycin to disrupt their gastrointestinal flora and render them potentially susceptible to C. difficile colonization. In this study, all subjects who received VP 20621 had positive non-toxigenic C. difficile stool cultures by day 6, suggesting that VP 20621 rapidly colonizes the susceptible GI tract.  The most common side effects observed following multiple doses of VP 20621 were mild loose or watery stools on a single study day that resolved despite continued dosing, mild burning sensation on the tongue, and mild dyspepsia.

About Vancocin® (vancomycin hydrochloride capsules, USP)

Vancocin® Capsules (vancomycin hydrochloride capsules, USP) is the only antibiotic approved to treat two significant bacterial infections of the lower digestive tract. It is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. Vancocin Capsules are contraindicated in patients with known hypersensitivity to vancomycin.

To reduce the development of drug-resistant bacteria and maintain
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SOURCE ViroPharma Incorporated
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