Linaclotide meets all endpoints in Phase III IBS trial
This article was originally published in Scrip
Ironwood/Forest/Almirall's guanylate cyclase agonist linaclotide met all its primary endpoints in its first Phase III trial in irritable bowel syndrome with constipation (IBS-C).. Results from a second, ongoing trial in IBS-C are due by the end of the year. Ironwood and Forest plan to submit an NDA for the drug in the US in mid-2011. Almirall has rights to linaclotide in Europe and the Commonwealth of Independent States (CIS) and will determine EU filing dates following the completion of the second trial.