Shire plc announced top-line results of the PREVENT2 trial, a Phase 3 investigational study of once-daily SPD476, MMX mesalamine in patients with a history of diverticulitis. The study, conducted in 10 countries worldwide including the United States, did not meet the primary endpoint in reducing the rate of recurrence of diverticulitis over a 2-year treatment period. In addition, SPD476, MMX mesalamine did not show a significant difference compared to placebo on the key secondary endpoint of the study.
“PREVENT2, a large, well-controlled trial, provided us with important information regarding diverticulitis.” said Dr Jeffrey Jonas, senior vice president of research and development for Shire’s Specialty Pharmaceuticals and Regenerative Medicine businesses. “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. Although the results of the second trial are pending, it is our current intention not to pursue a regulatory filing for this indication for MMX mesalamine.”
The objective of the PREVENT2 investigational study was to evaluate 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.
The primary efficacy measure was the proportion of patients without a recurrence of diverticulitis between three doses of SPD476, MMX mesalamine and placebo at week 104. Recurrence of diverticulitis was defined as: 1) the presence of each and all of the following three items: abdominal pain, a 15% increase in white blood cell count from baseline, and bowel wall thickening (>5mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan, or 2) surgical intervention for diverticular disease. The key secondary endpoint evaluated recurrence based on CT scan only.
There were no new safety observations identified in the PREVENT2 trial.
The PREVENT investigational program consists of two trials, PREVENT1 and PREVENT2. These are phase 3, randomized, double-blind, dose-response, stratified, placebo-controlled studies with an identical design. PREVENT2 randomized 592 subjects to receive once-daily SPD476, MMX mesalamine 1.2g, 2.4g or 4.8g, or placebo, over a period of 104 weeks. The PREVENT1 trial results are expected later this year.
Release date: March 30, 2012
Source: Shire plc
Filed Under: Drug Discovery