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)

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced top-line data from a Phase II trial evaluating MD-7246 in adult patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). The Phase II trial did not meet its primary or key secondary endpoints. Based on these findings, Ironwood and AbbVie plan to discontinue the development of MD-7246.

Results from a previously announced MD-7246 Phase II trial in adult patients with IBS with constipation (IBS-C) showed that MD-7246 numerically improved abdominal pain relative to placebo with no effect on bowel function. These data informed the companies’ decision to evaluate MD-7246 in the IBS-D population. Ironwood and AbbVie are now further examining the MD-7246 Phase II data in IBS-D to understand the discordance with the improvement in pain observed in the previous IBS-C results.

“We are disappointed by the results from this study; developing new and important treatment options for patients with GI diseases is a critical, but challenging undertaking. We are very grateful to the patients, investigators and researchers who participated, as well as to the Ironwood team and to our partner for executing a robust Phase II trial,” said Mark Mallon, chief executive officer of Ironwood. “Ironwood remains unwavering in its mission of advancing the treatment of GI diseases and redefining the standard of care for millions of GI patients. Ironwood is focused on continuing to drive strong LINZESS growth and completing the Phase III clinical program for IW-3718 in refractory gastroesophageal reflux disease, both of which we believe have the opportunity to help millions of GI patients in need.”

MD-7246 was generally well-tolerated in the Phase II trial in IBS-D; most adverse events were mild to moderate in severity. The most common adverse event for MD-7246 in this Phase II trial was upper respiratory tract infection/nasopharyngitis, which was observed at a similar frequency as placebo. In the Phase II trial in IBS-D, patients taking MD-7246 experienced no clinically meaningful effect on bowel function. Full results from this Phase II trial are expected to be submitted for presentation at a future medical meeting.