Ironwood initiates apraglutide NDA submission

Ironwood (IRWD) Pharmaceuticals announced a streamlined strategic focus on advancing and realizing the potential of apraglutide for the treatment of short bowel syndrome patients who are dependent on parenteral support. In line with this strategic update, Ironwood will be reducing its workforce by approximately 50%. This reorganization is intended to position the company for long-term growth. “Ironwood’s long track record of success stems from our ability to be nimble as an organization by focusing on both significant medical needs and financial performance. While LINZESS continues to grow prescription demand, given the impact of ongoing pricing pressures, we are taking steps to reduce Ironwood costs that are predominantly associated with the brand. By doing so, we believe we can continue to generate profits and cash flows and support the successful development of apraglutide. LINZESS remains an important part of our strategy, along with continued investment in apraglutide for SBS patients who are dependent on parenteral support, which we believe will deliver value to our stakeholders and ultimately bring a new therapy to patients with great unmet need,” said Tom McCourt, chief executive officer of Ironwood. “We have made important progress by initiating our rolling new drug application submission and announcing new data from our open label extension study, STARS Extend, demonstrating an increased number of patients on apraglutide achieving enteral autonomy over time. We plan to include the long-term extension data in our NDA submission, in addition to the robust efficacy and tolerability data from STARS, the largest Phase 3 clinical trial ever conducted in SBS-IF patients. With these new data, we are even more encouraged about apraglutide’s potential to help SBS patients who are dependent on parenteral support,” said Mike Shetzline, M.D., Ph.D, chief medical officer, senior vice president and head of research and drug development at Ironwood.