Ironwood Pharma Reports Top-Line Data from Exploratory Phase IIa Study of IW-9179 in DG

Ironwood Pharmaceuticals, Inc.

announced today that top-line data from an exploratory Phase IIa clinical study indicate IW-9179 did not meaningfully reduce the severity of symptoms in patients with diabetic gastroparesis. Based on these data, Ironwood intends to discontinue development of IW-9179 for gastroparesis. "Our mission is to bring innovative medicines to patients in need, and exploratory trials are designed to help us identify the investigational medicines and appropriate indications with the most potential to help patients," said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. "While these data indicate IW-9179 does not warrant advancement for gastroparesis, we recognize gastroparesis as a severely underserved disorder, and we want to extend our gratitude to the patients and health care professionals who participated in this study." The Phase IIa study was a randomized, double-blind, placebo-controlled study of oral IW-9179 administered to 90 patients with diabetic gastroparesis. Patients were randomized to receive IW-9179 or placebo once or twice daily for four weeks. Efficacy was evaluated through multiple patient assessments of cardinal symptoms associated with gastroparesis. Top-line data indicate IW-9179 did not meaningfully improve these symptoms relative to placebo. IW-9179 was generally well-tolerated with the most common adverse event being diarrhea, which was mostly mild to moderate in nature. Ironwood intends to discontinue development of IW-9179 for gastroparesis and focus on ongoing programs in three key franchises: irritable bowel syndrome with constipation/chronic idiopathic constipation, vascular and fibrotic disease, and refractory gastroesophageal reflux disease.