May 20 2011
ViroPharma Incorporated (Nasdaq: VPHM) today announced initiation of a Phase 2 dose-ranging clinical study to evaluate the safety, tolerability, and efficacy of VP 20621 for prevention of recurrence of Clostridium difficile infection (CDI) in adults previously treated for CDI.
The objectives of this randomized, double-blind, placebo-controlled, dose ranging study are to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; characterize the frequency and duration of stool colonization with VP 20621 strain of C. difficile; evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and select a dose regimen of VP 20621 to be used in future studies. Eligible subjects will have been diagnosed with CDI and treated with metronidazole or oral vancomycin. Subjects will be randomized into four different therapy groups, with study drug administered once daily after completion of CDI antibiotic treatment and continuing for up to 14 days. Each subject will be followed for a total of 6 months. The study will enroll at least 240 subjects, and will be conducted in North America and Europe.
"Recurrence of CDI represents a therapeutic challenge with substantial associated morbidity, mortality and compromised quality of life, often requiring prolonged and repeated treatment courses," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "There are no immediate solutions on the horizon for prevention of recurrent CDI following antibiotic treatment. However, based on the Phase 1 data with VP 20621, we are encouraged that this novel approach may one day fill this unmet clinical need."
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