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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
Date:4/22/2013

107 x 14d

All VP20621 dosesn

43

41

43

41

125NTCD detected in stool during

14 day administration period

0%

54%

79%

73%

69%p value vs. placebo<0.0001

<0.0001

<0.0001

<0.0001CDI Recurrence

30%

15%

5%

15%

11%p value vs. placebo0.11

<0.01

0.10

<0.01 Antibacterial Use for CDI

Treatment

33%

15%

9%

17%

14%p value vs. placebo0.06

0.02

0.14

<0.01 Event of diarrhea or loose stool

of any severity or duration

77%

56%

58%

56%

57%p value vs. placebo0.05

0.09

0.02

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
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  • SOURCE ViroPharma Incorporated
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