Cosmo Pharmaceuticals and partner Santarus report positive data from a U.S.- and India-based Phase III trial with ulcerative colitis candidate, budesonide MMX®. The firms say they hope to submit an NDA for the drug to FDA during the second half of 2011, assuming positive results from a parallel European study due to report in November and following the completion of an ongoing placebo-controlled extended use trial.
The latest Phase III data showed that treatment with budesonide MMX 9 mg for eight weeks was more effective than placebo at achieving clinical remission from mild-to-moderate active ulcerative colitis, as measured by the ulcerative colitis disease activity index (UCDAI) score. Of patients receiving once-daily budesonide MMX 9 mg, 17.9% achieved remission compared with 13.2% treated once daily with a 6 mg dose, 12.1% of patients given thrice-daily Asacol® (mesalamine) as a reference, and 7.4% of placebo-treated patients.
The Phase III program for budesonide MMX also includes a European study, which is due to report within the next few weeks. It compared once-daily budesonide MMX 9 mg or 6 mg with placebo. The reference arm in this trial used Entocort EC® (budesonide) thrice daily. Cosmo notes that neither of the two Phase III studies was powered to show statistical differences between budesonide MMX, Asacol, and Entocort.
Meanwhile an additional, FDA-requested 12-month extended use study is ongoing to support U.S. regulatory submission. This placebo-controlled trial, in the U.S. and India, is evaluating the long-term safety and tolerability of budesonide MMX 6 mg and efficacy of the drug in maintaining remission from ulcerative colitis. Study completion is scheduled for mid-2011.
Budesonide MMX has been developed using Cosmo’s multi-matrix MMX system to allow the controlled release and distribution of budesonide throughout the length of the colon. Santarus negotiated exclusive rights to develop and commercialize budesonide MMX® and the antibiotic rifamycin SV MMX® in the U.S. back in 2008. In June 2010, Santarus started enrolling patients into the first Phase III trial evaluating rifamycin SV MMX for the treatment of travelers' diarrhea.