Ironwood, Allergan Report Topline Phase IIb Data For Linaclotide CR2

(RTTNews) - Ironwood Pharmaceuticals Inc. (IRWD) and Allergan plc (AGN) announced topline data from a Phase IIb clinical trial evaluating an investigational linaclotide colonic release-2 or CR2 formulation in adult patients with irritable bowel syndrome with constipation or IBS-C.

The data showed that CR2, as intended, numerically improved abdominal pain and other abdominal symptoms, such as bloating and discomfort, relative to placebo, with no apparent effect on bowel movement function.

The companies noted that the findings support further investigation of CR2 in specific GI indications where patients experience abdominal pain but are not necessarily constipated, such as IBS-Mixed, IBS with diarrhea, ulcerative colitis and diverticulitis.

The companies plan to engage with the U.S. Food and Drug Administration to discuss next steps for advancing CR2 into a Phase IIb dose-ranging clinical trial in patients with non-constipation subtypes of IBS.

Linaclotide is currently FDA-approved and available in an immediate release formulation, Linzess, for the treatment of adults with IBS-C or chronic idiopathic constipation or CIC.