Ironwood Scores Phase III Success, Yet Shares Plunge

Boston-based pharmaceutical company Ironwood Pharmaceuticals reported positive Phase III findings for its GLP-2 analog drug, apraglutide, which is intended to lessen the reliance on parenteral support (PS) in adults with short bowel syndrome (SBS), a serious condition that may lead to organ failure. Despite the promising results, the market did not respond favorably, and Ironwood’s stock price plummeted by nearly 40%.

The STARS trial showed that apraglutide significantly reduced the weekly PS volume by more than 25% compared to a 12% reduction in the placebo group, with a highly significant p-value of 0.001, indicating the drug met its primary endpoint. Additionally, the drug performed well in four secondary endpoints, where a higher percentage of patients in the treatment group were able to discontinue PS for at least one day or a week compared to the placebo group, with a p-value of 0.040.

However, Ironwood acknowledged that while apraglutide showed numerical improvements in other endpoints, these did not reach statistical significance. The company is still optimistic about the drug's potential and plans to submit a New Drug Application (NDA) and other regulatory documents, although no specific timeline has been provided.

Ironwood's CFO, Michael Shetzline, expressed gratitude to the participants and researchers involved in the study and stated that the company is committed to working with regulatory bodies to make apraglutide available to SBS patients. The drug was acquired by Ironwood in May 2023 as part of a $1 billion deal to acquire VectivBio, which broadened Ironwood's gastrointestinal product range.

The pharmaceutical market for SBS is competitive, with Takeda’s Gattex already approved since 2019. Other companies, such as Zealand Pharma and Entera Bio, are also progressing with their GLP-2 candidates for treating the condition. Despite the competition, Ironwood remains hopeful about apraglutide's prospects in improving the treatment options for SBS patients.