Shire's MMX mesalamine induced remission in patients with ulcerative colitis

By Lisa Kerner

Erie, Pa., May 24 - Results of two pivotal phase 3 clinical studies (301 and 302) of a novel formulation of Shire plc's Multi-Matrix System (MMX) mesalamine demonstrated that MMX mesalamine induced remission in patients with active mild-to-moderate ulcerative colitis and was generally well tolerated at once-daily and twice-daily dosing.

The results were presented at the today during Digestive Disease Week in Los Angeles, according to a company news release.

Mesalamine is used as a first-line treatment for mild to moderate ulcerative colitis, while MMX mesalamine uses a novel proprietary MMX technology to provide the highest mesalamine dose per tablet.

Shire said the randomized, multicenter, double-blind phase 3 studies examined the efficacy and tolerability of MMX mesalamine in both once-daily and twice-daily dosing.

Statistically significant results were demonstrated at week 8 when a greater population of patients (37.2%) achieved remission in the MMX mesalamine 2.4 g/day group compared with the placebo group (17.5%). Similar results were found in the MMX mesalamine 4.8 g/day QD group compared to placebo.

In a second analysis of the combined data, at week 8 patients with left-sided or extensive ulcerative colitis receiving MMX mesalamine achieved remission compared with placebo.

Shire said it is continuing to develop MMX mesalamine, which is licensed from Giuliani SpA for commercialization in the United States, Canada and Europe excluding Italy.

Shire is a Basingstoke, U.K.-based specialty pharmaceutical company.

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