Ironwood Pharmaceuticals (IRWD, Financial) has announced its intent to conduct a new Phase 3 trial for apraglutide following a recent dialogue with the FDA. This decision is crucial for obtaining approval for the treatment targeted at patients with short bowel syndrome with intestinal failure (SBS-IF), who are reliant on parenteral support.
Apraglutide, a synthetic GLP-2 analog administered weekly, has shown a significant reduction in the volume of parenteral support required, marking it as a promising option for individuals with rare gastrointestinal disorders. Despite promising results from the STARS Phase 3 trial — the largest of its kind for SBS-IF — the FDA requires additional confirmatory evidence for approval.
The company has enlisted Goldman Sachs to assess various strategic alternatives to enhance shareholder value, while continuing the advancement of apraglutide. Ironwood plans to work closely with the FDA to design the new trial and move forward with regulatory submissions.
In the STARS Phase 3 trial, a significant data point was that 27 patients achieved enteral autonomy, an integral goal for those dependent on parenteral support. The safety and efficacy data from both the STARS Phase 3 trial and its long-term extension will remain foundational to the future NDA submission.
Ironwood remains committed to improving treatment options for patients with SBS-IF and plans to continue building on the data collected to strengthen their case for apraglutide's approval.
