Additional Relevant Details
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.