Ironwood Pharmaceuticals said today it will halt development of IW-9179 for diabetic gastroparesis following the failure of a Phase IIa clinical trial in the indication.
Ironwood acknowledged that IW-9179 did not meaningfully reduce the severity of symptoms in diabetic gastroparesis patients compared with placebo: “The data were not what we all hoped for,” the company stated in a Twitter tweet.
Instead, Ironwood said, it will focus on ongoing drug-development programs in three franchises—irritable bowel syndrome with constipation/chronic idiopathic constipation, vascular and fibrotic disease, and refractory gastroesophageal reflux disease.
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 4 weeks. Ironwood said it assessed efficacy through multiple patient assessments of cardinal symptoms associated with gastroparesis.
Despite the lack of meaningful improvement of symptoms, IW-9179 was generally well tolerated, with the most common adverse event being diarrhea, which Ironwood said was mostly mild to moderate in nature.
The decision comes 2 years after Ironwood terminated a Phase II study of IW-9179 in functional dyspepsia (NCT01712412) before completing enrollment. In a statement at the time, the company cited “challenges with the rigorous enrollment exclusion criteria in the trial,” and added that preliminary data supported continued development. IW-9179 is still listed as being in development for functional dyspepsia on the company’s pipeline website page, last updated February 18.