Ironwood to discontinue IW-3718 development program of IW-3718 in refractory gastroesophageal reflux disease following results from planned efficacy assessment.

Ironwood Pharmaceuticals, Inc. a GI-focused healthcare company, announced that data from IW-3718-302, one of Ironwood’s two identical Phase III trials evaluating IW-3718 in refractory gastroesophageal reflux disease (GERD), did not meet the pre-specified criteria associated with a planned early efficacy assessment. Following the assessment from an independent data monitoring committee, Ironwood unblinded the data and confirmed that IW-3718-302 did not meet the criteria, including the study’s primary endpoint of achieving a statistically significant improvement in heartburn severity. IW-3718 was generally well-tolerated in study IW-3718-302. Based on these findings, Ironwood plans to discontinue development of IW-3718, including stopping enrollment in IW-3718-301, the second Phase III trial.