Ironwood Pharmaceuticals announced data from the one of two identical Phase III trials evaluating IW-3718 in refractory gastroesophageal reflux disease (GERD). The trial 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.
Based on these findings, Ironwood plans to discontinue development of IW-3718, including stopping enrollment in IW-3718-301, the second Phase III trial.
In July of 2020 the company reached an agreement with the FDA to update its IW-3718 Phase III trials that resulted in changing the trials’ primary endpoint from a previous responder endpoint to a continuous endpoint. The company had planned to halt trial and conduct a blinded early assessment of the efficacy data.
Ironwood presented data from a Phase IIb trial evaluating IW-3718 in persistent GERD during a distinguished abstract plenary oral session at Digestive Disease Week in July of 2018. The data demonstrated that IW-3718 plus a PPI significantly reduced heartburn severity and showed reductions in frequency of regurgitation
In conjunction with discontinuing the development of IW-3718, Ironwood plans to implement an organizational restructuring, reducing nearly 35% of the current workforce, in addition to restructuring its commercial organization.