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news.ViroPharma has commenced a randomized, double-blind, placebo-controlled, dose ranging Phase 2 study to investigate VP 20621 to prevent recurrence of Clostridium difficile infection (CDI) in adults who were formerly treated for CDI.
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The main objective of the trial is to assess 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.
The trial also aims to 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.
The study is expected to recruit around 240 subjects in North America and Europe.
ViroPharma chief scientific officer Colin Broom said 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," Broom said.