Business
Ironwood to Discontinue IW-3718 Development Program Following Results from Planned Efficacy Assessment
– Trial did not achieve statistically significant improvement in heartburn severity (primary endpoint) – – Ironwood plans to implement organizational
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Trial did not achieve statistically significant improvement in heartburn severity (primary endpoint) –\n\n– Ironwood plans to implement organizational restructuring, resulting in expected headcount reduction of approximately 100 full-time employees, or nearly 35% of current workforce – \n\n– Expects total cost savings of greater than $95 million, excluding anticipated one-time costs –\n\n– Conference call to be held today at 8:30 a.m. ET –\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today 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.\n\nBased on these findings, Ironwood plans to discontinue development of IW-3718, including stopping enrollment in IW-3718-301, the second Phase III trial.\n\n“The outcome of this assessment is deeply disappointing for Ironwood and for patients, given the large unmet need among patients with refractory GERD for an alternative to standard treatment options,” said Mark Mallon, chief executive officer of Ironwood. “IW-3718-302 was a robust and well-conducted Phase III trial, and while we plan to conduct a complete analysis of the data set, we believe these findings are definitive. We extend our gratitude to the patients, investigators and their staff and the entire Ironwood team who played a critical role in advancing IW-3718.”\n\nIronwood plans to implement an organizational restructuring, reducing headcount by approximately 100 full-time employees, or nearly 35% of the current workforce. This is expected to affect both field-based and home-office employees, including the relevant general & administrative support functions. Following the changes, Ironwood expects to have approximately 210 full-time employees. The planned workforce reduction is anticipated to be substantially completed in the first quart...