Santarus, Inc. (NASDAQ: SNTS) today announced that results from its CORE II clinical study, one of two of the company’s pivotal Phase III clinical studies with UCERIS ™ (budesonide) extended release tablets in patients with ulcerative colitis, have been published online in the peer-reviewed journal Gut. The article titled, Once-daily budesonide MMX ® in active mild-to-moderate ulcerative colitis: results from the randomized CORE II study can be found online at http://gut.bmj.com/.
The results from CORE II indicate that UCERIS 9 mg had a statistically significant benefit over placebo in the primary endpoint of inducing combined clinical and endoscopic remission at week 8 among patients with active, mild to moderate ulcerative colitis. A total of 410 patients across four treatment groups (placebo, UCERIS 9 mg, UCERIS 6 mg and Entocort EC ® 9 mg) were evaluated for efficacy in the CORE II study. The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at week 8 in the UCERIS 9 mg group was significantly greater than that seen in the placebo group (17.4% vs. 4.5%, p= 0.0047; odds ratio (OR): 4.49). The U.S. Food and Drug Administration (FDA) approved UCERIS 9 mg for the induction of remission in patients with active, mild to moderate ulcerative colitis on January 14, 2013.
“UCERIS 9 mg looks like a useful treatment option for the induction of remission in patients with active, mild to moderate ulcerative colitis,” said Simon P. L. Travis, M.D., Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom and lead author of the article in Gut.
Efficacy endpoints were prespecified in the statistical analysis plan to be analyzed in the modified intention to treat (ITT) population (all randomized patients who received at least one dose of study medication, with active histological disease at baseline and no major violations of Good Clinical Practices (GCP) or entry criteria (i.e., infectious colitis)), consistent with the 2008 European Medicines Agency guidelines on clinical trials of active ulcerative colitis. Active disease was determined via a central histopathologist.