Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that its collaboration partner, Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), has completed enrollment of 514 patients in the European Phase III clinical trial to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the first of two induction phase clinical trials being conducted as part of the budesonide MMX Phase III clinical program. Santarus and Cosmo expect to report preliminary top line results from the European Phase III clinical trial in the first half of 2010. The U.S. Phase III budesonide MMX clinical trial is approximately 60% enrolled.
“We are pleased to reach this significant milestone in the budesonide MMX Phase III clinical program,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We look forward to announcing the results of this trial and completing the induction phase of the U.S. budesonide MMX Phase III trial during the first half of 2010.”
Budesonide MMX Phase III Clinical Program
Budesonide MMX is being evaluated for the treatment of ulcerative colitis in two Phase III clinical trials, both of which are intended to support U.S. regulatory submission. The primary endpoint is the percentage of patients achieving clinical remission in each of the budesonide MMX treatment groups versus placebo as measured by the ulcerative colitis disease activity index (UCDAI) after eight weeks of treatment. The Phase III clinical program is expected to enroll approximately 1,000 patients in the two studies.
Each clinical trial is a double-blind, placebo-controlled, four-armed trial.