Positive Phase III Results for Once-Weekly Apraglutide in Adult SBS-IF Patients

Ironwood Pharmaceuticals, a company specializing in gastrointestinal health, has reported encouraging results from a Phase III clinical trial of apraglutide, a weekly GLP-2 analog. The study, known as STARS, aimed to assess the drug's effectiveness in reducing the need for parenteral support (PS) among adults with short bowel syndrome with intestinal failure (SBS-IF). This condition, which impacts an estimated 18,000 adults in the U.S., Europe, and Japan, requires patients to rely on PS due to the failure of their intestines.

The STARS trial, which was a global, multicenter, double-blind, randomized, and placebo-controlled study, involved weekly subcutaneous injections of apraglutide. It demonstrated a significant reduction in weekly PS volume at the 24-week mark, with a relative change of -25.5% for apraglutide compared to -12.5% for the placebo group, indicating a clear benefit of the treatment.

Dr. Kishore R Iyer, a leading expert in the field and the coordinating principal investigator of the trial, underscored the importance of reducing PS dependency for SBS-IF patients. He noted that the STARS trial's success marks a significant milestone as it is the first Phase III study of its kind to show positive results with a once-weekly GLP-2 analog.

The trial also examined four secondary endpoints, with apraglutide showing statistical significance in two of them. More patients treated with apraglutide were able to go at least one day per week without PS, and there was a notable improvement in the stoma population's weekly PS volume. However, the drug did not achieve statistical significance in the remaining two endpoints related to colon-in-continuity patients.

Safety was a key consideration in the trial, and apraglutide was found to be well-tolerated with a safety profile in line with previous studies. Michael Shetzline, Ironwood's chief medical officer, highlighted the potential of apraglutide to improve the lives of SBS-IF patients by reducing the burden of their condition and treatment.

Following the positive results, Ironwood plans to submit a new drug application for apraglutide and is preparing to share more data from the STARS trial at future medical conferences. The company is optimistic about the drug's potential to redefine the standard of care for SBS-IF patients who are dependent on PS.

Short bowel syndrome is a serious condition characterized by reduced intestinal absorption, often necessitating long hours of PS infusions daily. This not only affects patients' quality of life but also exposes them to risks such as infections. The STARS trial represents the largest Phase III study for SBS-IF to date, conducted across 18 countries with 68 active sites.

Apraglutide is an investigational drug being developed for gastrointestinal diseases where GLP-2 plays a crucial role in disease management. Ironwood Pharmaceuticals, a leader in GI healthcare, is committed to advancing treatments for GI diseases and improving patient care. The company's flagship product, LINZESS, is a leading prescription for adults with IBS-C or CIC and is also indicated for pediatric patients with functional constipation.

Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with an additional site in Basel, Switzerland. The company routinely shares important updates on its website and maintains a presence on social media platforms. With the positive results from the STARS trial, Ironwood is poised to contribute significantly to the treatment of SBS-IF and other gastrointestinal conditions.