Ironwood Presents IW-9179 Phase IIa Data At American College Of Gastroenterology 2014 Annual Scientific Meeting

Ironwood Pharmaceuticals, Inc.

announced today the presentation of initial data from a Phase IIa clinical study in functional dyspepsia with IW-9179, an investigational guanylate cyclase-C (GC-C) agonist designed to target the upper gastrointestinal (GI) tract. These data will be presented during the American College of Gastroenterology 2014 Annual Scientific Meeting in Philadelphia, October 17 through October 22, 2014. Ironwood expects to initiate a Phase IIa clinical study evaluating IW-9179 in a second therapeutic area, gastroparesis, before the end of the year. Gastroparesis is an upper GI disorder that impacts an estimated 9 million Americans and is characterized by nausea, vomiting, bloating, early satiety and pain. “As innovators in the science of guanylate cyclase-C, Ironwood created the first and only FDA-approved GC-C agonist, which is indicated for two lower gastrointestinal disorders. We are encouraged by the initial IW-9179 data and our other recent data indicating GC-C agonists may also have utility in treating upper gastrointestinal disorders,” said Dr. Michael Hall, MB. BCh., senior vice president, clinical development of Ironwood. “Common upper GI disorders such as gastroparesis and functional dyspepsia remain areas where millions of suffering patients are in need of effective therapies.” The Phase IIa clinical study of IW-9179 was a randomized, double-blind study in 10 patients (six on IW-9179, four on placebo) with functional dyspepsia (FD). Patients treated with IW-9179 reported a numerically greater improvement from baseline, compared with placebo-treated patients, on six out of seven FD symptoms evaluated, including epigastric pain, epigastric bloating, postprandial fullness, early satiation, nausea and belching. The most common adverse event in IW-9179-treated patients was diarrhea. Enrollment in this study was limited by stringent enrollment criteria that sought to identify patients suffering only from GI symptoms of FD - a difficult task given that FD sufferers frequently also have symptoms of other GI disorders such as gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS). In fact, of the 58 patients who initially met the stringent enrollment criteria and completed the 14-day pretreatment period, 78% were not qualified to enter the study treatment period owing to overlapping GI symptoms. These data inform Ironwood's continued work with gastrointestinal experts and regulatory authorities to define the path to bring forward new therapies in FD. These data will be presented in the poster, Evaluation of Daily GI Symptoms in a Phase 2a Study of IW-9179 in Functional Dyspepsia (abstract #P1637) on Tuesday, October 21, 2014, 10:30 a.m. to 4:00 p.m., Eastern Time. Jan Tack, MD, Ph.D., Head of Clinic in the Department of Gastroenterology, and Professor of Internal Medicine at the University of Leuven, Belgium, is the lead investigator and first author.