Philadelphia, PA October 15, 2007 Post-hoc and other analyses of secondary endpoints of a long-term safety and tolerability study of Shire plc's (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) ulcerative colitis (UC) drug LIALDA (mesalamine) provide further data on LIALDA in patients with mild to moderate ulcerative colitis. These analyses of LIALDAs 303 trial, a long-term, Phase III, open-label 12-14 month extension study, are being presented this week at The American College of Gastroenterology (ACG) meeting in Philadelphia.
The primary endpoint of study 303 was safety and tolerability and findings that LIALDA is generally well tolerated in mild to moderate UC patients were presented at the British Society of Gastroenterology (BSG) meeting in Glasgow, Scotland in March 2007.
"Earlier studies showed that LIALDA is well-tolerated and effective at inducing remission in patients with active, mild to moderate UC. Post-hoc analysis of secondary endpoints provided evidence that LIALDA maintained remission in a variety of UC patients, said Gary R. Lichtenstein, M.D., director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania.
A summary of key scientific presentations of post-hoc analyses of secondary endpoints of study 303 follows.
Once or Twice Daily Lialda for Mild vs. Moderate Ulcerative Colitis
Poster Presentation: Tuesday, October 16, 2007, Exhibit Hall B, #950
A post-hoc analysis of secondary endpoints from the long-term 303 study was performed to review the efficacy of LIALDA for maintaining remission in patients with mild versus moderate ulcerative colitis. In the 303 study, patients were randomized to receive LIALDA 2.4g/day (given once daily [QD]) or 2.4g/day (1.2g given twice daily [BID]). Study 303 defined patient remission using stringent clinical and endoscopic measures: modified UC Disease Activity Index (UC-DAI) score of ≤1 with score
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