Shire's SPD476 leads to remission in ulcerative colitis patients, studies show

By E. Janene Geiss

Philadelphia, Nov. 1 - Shire Pharmaceuticals Group plc announced Tuesday that results of phase II clinical studies of an advanced formulation of high-strength mesalamine, SPD476, show that it met its primary endpoint of inducing remission in patients with ulcerative colitis.

Although mesalamine is routinely used to treat ulcerative colitis, SPD476 uses an advanced proprietary Multi-Matrix System technology to provide the highest mesalamine dose per tablet and deliver delayed and extended medication consistently through the colon, company officials said in a news release.

The results of the study were presented at the annual meeting of the American College of Gastroenterology.

Officials said the trial was a double-blind, multi-center phase III study on 343 randomized patients with ulcerative colitis (UC) to test the efficacy and tolerability of the drug compared to placebo.

"This study shows that once-daily SPD476 achieved the rigorous endpoint of induction of remission and was well tolerated for the treatment of UC," Dr. William Sandborn, a key author of the study, said in the release. "These findings are very important to advancing UC therapy."

A second pivotal phase III study on 280 patients designed to evaluate the safety and efficacy of SPD476 given once-daily or twice-daily versus placebo demonstrated that once-daily dosing provided the highest percentage of remission in patients. A once-daily dose could increase patient compliance, officials said.

Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize SPD476 in the United States, Canada and Europe, except Italy, officials said.

Shire Pharmaceuticals, is a Basingstoke, England-based pharmaceutical company.

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