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Treatment With VP20621 (Non-Toxigenic Clostridium difficile; NTCD) In A Phase 2 Study Resulted In High Rates Of Colonization And Statistically Significant Reductions In Recurrence Of C. difficile Infection

107 x 14d

All VP20621 dosesn





125NTCD detected in stool during

14 day administration period





69%p value vs. placebo<0.0001



<0.0001CDI Recurrence





11%p value vs. placebo0.11



<0.01 Antibacterial Use for CDI






14%p value vs. placebo0.06



<0.01 Event of diarrhea or loose stool

of any severity or duration





57%p value vs. placebo0.05



0.02Safety:VP20621 exhibited a favorable tolerability profile:

  • There were no notable differences in adverse events between the different VP20621 dose groups;
  • Overall, treatment-emergent adverse events were reported in 86 percent of placebo subjects and 78 percent of all VP20621 subjects;
  • Treatment-emergent serious adverse events were reported in 7 percent and 3 percent of placebo and VP20621 subjects, respectively, though none were considered related to study drug;
  • Diarrhea events are shown in the table above. Abdominal pain was reported in 33 percent of placebo subjects and 17 percent of all VP20621 subjects;
  • The only adverse event with apparent association with VP20621 was headache: Two percent for placebo subjects vs. 10 percent for all VP20621 subjects;
  • There were 2 deaths:
  • One subject in the placebo group had severe recurrent CDI that did not respond to attempted fecal transplant; death was attributed to the CDI and subsequent respiratory failure;
  • One subject in the VP20621 high-dose (14 day) group was diagnosed with recurrent CDI and fell a

  • SOURCE ViroPharma Incorporated
    Copyright©2012 PR Newswire.
    All rights reserved

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