Ironwood, Allergan Report Topline Phase IIb Data For Linaclotide CR-1 In IBS-C

(RTTNews) - Ironwood Pharmaceuticals Inc. (IRWD) and Allergan plc (AGN) announced positive topline data from a Phase IIb clinical trial evaluating the investigational linaclotide colonic release-1 or CR1 formulation in adult patients with irritable bowel syndrome with constipation or IBS-C.

The companies noted that topline data in the trial demonstrated numerically greater abdominal pain improvement with CR1 300 mcg compared to placebo and to the 290 mcg immediate release or IR formulation of linaclotide.

The double-blind, placebo-controlled, dose-ranging Phase IIb trial randomized 532 adult patients with IBS-C into one of eight possible treatment arms.

The companies intend to engage with the U.S. Food and Drug Administration to discuss Phase III development plans, with trials in adults with IBS-C expected to begin in the second half of 2017.

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

This clinical trial was designed to evaluate whether CR1 could further decrease the activity of key pain-sensing nerves in the distal smallintestine and colon while maintaining an effect on fluid secretion.