Ironwood and AbbVie Report Top-line Phase II Data for MD-7246 in Patients with Abdominal Pain Associated with Irritable Bowel Syndrome with Diarrhea (IBS-D) - Seite 2

MD-7246 Phase II IBS-D Trial Design

The randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding Phase II study was designed to evaluate the safety, tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to adult patients with abdominal pain associated with IBS-D. 388 IBS-D patients were randomized equally across three dose levels of MD-7246 (300, 600 or 1,200 mcg), or matching placebo, administered once daily. The primary efficacy endpoints were change from baseline in abdominal pain at its worst each week and an overall abdominal pain response, defined as at least a 30% reduction from baseline in abdominal pain for at least 6 out of 12 weeks.

For additional information about this clinical trial, please visit www.clinicaltrials.gov.

Previous MD-7246 Phase II Results in IBS-C

In December 2016, Ironwood reported top-line results from a Phase II clinical trial evaluating MD-7246 in adult patients with irritable bowel syndrome with constipation (IBS-C). Results from the double-blind, placebo-controlled, dose-ranging Phase IIb trial showed that MD-7246 numerically improved abdominal pain and other abdominal symptoms, such as bloating and discomfort, relative to placebo, with no effect on bowel movement function. Percent change from baseline at week 12 in abdominal pain ranged from -33.8% to -36.6% for the MD-7246 doses compared to -26.2% for placebo. The most common adverse event in MD-7246 patients was anemia. The rate of diarrhea reported in the trial ranged from 0% to 3% for MD-7246-treated patients compared to 1.5% for placebo.

About MD-7246

MD-7246 is a delayed release formulation of linaclotide that was being evaluated by Ironwood and its partner AbbVie as an oral, non-opioid, pain-relieving agent for adult patients in the U.S. suffering from abdominal pain associated irritable bowel syndrome with diarrhea (IBS-D). MD-7246 was designed to provide targeted delivery of linaclotide to the colon, where the majority of the abdominal pain associated with IBS is believed to originate, and to limit fluid secretion in the small intestine resulting in minimal impact on bowel function.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). We are also advancing IW-3718, a gastric retentive formulation of a bile acid sequestrant being developed for the potential treatment of refractory gastroesophageal reflux disease. IW-3718 is first-in-category product candidate currently in Phase III clinical trials.