UROV - Mid-stage study of Urovant Sciences' vibegron in irritable bowel syndrome fails to meet primary endpoint
Urovant Sciences (UROV) reports topline data from the Phase 2a trial evaluating once-daily vibegron 75 mg in women with abdominal pain due to irritable bowel syndrome ((IBS)) with IBS-D (diarrhea) and IBS-M (mixed IBS). A total of 222 female IBS patients were enrolled, 189 of whom completed the 12-week study.In the primary efficacy analysis, the study did not meet the primary endpoint with 40.9% of vibegron IBS-D patients achieving at least a 30% improvement in abdominal pain, compared to 42.9% in the placebo group. The most important secondary endpoint demonstrated 42.4% of Global Improvement Scale in the vibegron group, compared with 33.3% for placebo but this was not statistically significant for the IBS-D, IBS-M or the overall IBS population.Urovant will continue to analyze the full data set of this study. Vibegron was very well tolerated in the study and did not lead to any worsening of IBS symptoms.Discontinuation rates due to adverse
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Mid-stage study of Urovant Sciences' vibegron in irritable bowel syndrome fails to meet primary endpoint