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news.Shire has reported top-line results from the PREVENT2 trial of once-daily SPD476, MMX mesalamine in patients with a history of diverticulitis.
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The Phase III investigational study did not meet the primary endpoint in reducing the rate of recurrence of diverticulitis over a two-year treatment period.
The SPD476, MMX mesalamine did not show a significant difference compared to placebo on the key secondary endpoint of the study, the company said.
The objective of the study was to assess the safety and efficacy of SPD476, MMX mesalamine versus placebo in reducing the incidence of recurrent attacks of diverticulitis in patients with a history of at least one prior attack.
Shire Specialty Pharmaceuticals and Regenerative Medicine businesses R&D senior vice president Jeffrey Jonas said PREVENT2, a large, well-controlled trial, provided the company with important information regarding diverticulitis.
"We will continue to analyze these data and those of the second study, PREVENT1, which was similar in design to PREVENT2 and will report later in the year," Jonas added.