Linaclotide meets IBS-C endpoints
Almirall S.A. (Madrid:ALM) and Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) said once-daily oral linaclotide met all co-primary and secondary endpoints vs. placebo in the Phase III LIN-MD-31 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 throughout the 12 week treatment period. The double-blind, North American trial enrolled 803 patients.
An NDA submission in the U.S. is expected in mid-2011. A submission date in Europe will be determined after data from a second Phase III trial, which is expected to be reported next quarter. ...