Linaclotide meets IBS endpoints

Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) and its partners said once-daily oral linaclotide met all co-primary and secondary endpoints vs. placebo in the Phase III MCP-103-302 trial to treat irritable bowel syndrome with constipation (IBS-C). The guanylate cyclase C ( GCC; GUCY2C) agonist met the four co-primary endpoints required for an FDA analysis, as well as the two co-primary endpoints required by the European Medicines Agency (EMA). The endpoints included various measures of abdominal pain, discomfort and bowel movement. The double-blind, U.S. trial enrolled 805 patients.

In September, linaclotide met all co-primary and secondary endpoints vs. placebo in the Phase III LIN-MD-31 trial to treat IBS-C. ...