Shire's MMX mesalazine performs well in UC studies

UK-based drugmaker Shire says that data from trials of its drug MMX mesalazine, a once-daily oral treatment for mild-to-moderate ulcerative colitis, show that it is effective in inducing remission. The findings were presented at the 14th United European Gastroenterology Week congress in the German capital, Berlin.

The results, which are from two, randomized placebo-controlled Phase III studies that enrolled 517 UC patients, showed that 37.2% of those who received 2.4g/day, and 35.1% treated with 4.8g/day, achieved remission, compared with only 17.5% of the placebo group. In addition, in subjects who had not previously received 5-aminosalicylic acid, the standard treatment, the percentages of those who achieved remission in each dosage group were 42.9% and 33.0%, respectively.

The company added that the drug was well tolerated at both dosages and had a safety profile similar to other mesalazine formulations. 10 trial participants experienced serious adverse events, seven of whom had been treated with placebo.