Phase 3 Study of Uceris for Ulcerative Colitis

Santarus announced pooled data from two Phase 3 studies of Uceris (budesonide MMX) for the induction of remission of mild or moderate active ulcerative colitis. The pooled data from the two clinical studies analyzed 672 patients in the pre-defined intent to treat (ITT) population who were treated with Uceris 9mg tabs (N=232), Uceris 6mg tabs (N=230) or placebo (N=210). The pooled ITT population excluded study patients without histological evidence of active disease at baseline or with major eligibility or Good Clinical Practice violations.

Uceris 9mg was statistically superior to placebo (17.7% vs. 6.2%; P=0.0002) in clinical and endoscopic remission and in symptom resolution. Symptom resolution was 26.3% for Uceris 9mg vs. 14.3% for placebo (P=0.0015). Clinical improvement (P=0.0572) and endoscopic improvement (P=0.0410) were both numerically greater for Uceris 9mg than placebo, but not statistically significant at α=0.025, which was used due to multiple testing of two active treatment arms. Treatment-emergent adverse events, including potential glucocorticoid effects, occurred with similar frequencies across all study groups. The most common treatment-emergent adverse events were ulcerative colitis, headache, nausea, abdominal pain, musculoskeletal and connective tissue disorders and nasopharyngitis.

Uceris is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes proprietary MMX multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. 

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