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Home Industry News Shire Pharmaceuticals present results of ulcerative colitis study

Shire Pharmaceuticals present results of ulcerative colitis study

2nd November 2005

Shire Pharmaceuticals has presented the results of its Mesavance (SPD476) phase III ulcerative colitis (UC) study which showed it met its primary endpoint of induction of remission of active, mild-to-moderate UC and was well tolerated as once-daily and twice- daily dosing.

SPD476 is a novel, high-dose 5-aminosalicylic acid (5-ASA; mesalamine) in a delayed and extended release formulation being studied for the induction of remission of active, mild-to-moderate ulcerative colitis.

Presented at the 70th Annual American College of Gastroenterology, Shire revealed that although mesalamine is routinely used for the treatment of UC, SPD476 successfully utilises an advanced proprietary Multi-Matrix System (MMX) technology to provide the highest mesalamine dose per tablet (1.2g) and deliver delayed and extended medication consistently through the colon.

Results of two Phase III clinical studies (301 and 302) were presented.

The 302 study was a double-blind, multi-centre Phase III study that studied the efficacy and tolerability of SPD476 compared to placebo.

Results showed a statistically significantly greater population of patients receiving SPD476 2.4g (once daily) or 4.8g achieved remission compared to placebo (primary endpoint).

“This study shows that once-daily SPD476 achieved the rigorous endpoint of induction of remission and was well tolerated for the treatment of UC,” said Dr William Sandborn, author of the 302 study.

“These findings are very important to advancing UC therapy.”

Study 301, was a multi-center, prospective, double-blind study designed to evaluate the safety and efficacy of SPD476 given once daily or twice daily versus placebo in adult patients with acute, mild-to-moderate UC, it also showed SPD467 achieving remission in a statistically significantly higher proportion of patients compared to the placebo.

Shire is continuing the development of SPD476 and has licensed from Giuliani the exclusive right to develop and commercialise SPD476 in the US, Canada and Europe (excluding Italy).

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