BOSTON - Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD), a healthcare company focused on gastrointestinal treatments, announced today positive topline results from the Phase III STARS trial of apraglutide, a treatment for adult patients with short bowel syndrome with intestinal failure (SBS-IF).
The trial met its primary endpoint, showing a significant reduction in weekly parenteral support (PS) volume at week 24 when compared with a placebo.
The global trial involved 164 patients and demonstrated a 25.5% reduction in PS volume for those treated with apraglutide versus a 12.5% reduction for those given a placebo. Moreover, 43% of patients receiving apraglutide achieved at least one day per week without PS at week 24, compared to 27.5% for the placebo group.
Kishore R Iyer, the trial's Coordinating Principal Investigator, highlighted the significance of these findings, noting the importance of reducing dependency on PS for patients with SBS-IF. While the trial's third and fourth key secondary endpoints were not met, apraglutide showed a favorable trend.
The safety profile of apraglutide was consistent with previous studies, with the drug being generally well-tolerated among participants. Michael Shetzline, M.D., Ph.D., chief medical officer at Ironwood, expressed confidence in the potential of apraglutide to improve care for SBS patients dependent on PS.
Following these results, Ironwood plans to submit a new drug application (NDA) and other regulatory filings for the approval of apraglutide. Additional data from the STARS study is expected to be presented at medical conferences later this year.
SBS-IF is a debilitating condition that affects an estimated 18,000 adult patients in the U.S., Europe, and Japan. It often leads to a heavy treatment burden, including the need for lengthy daily PS infusions, impacting patients' quality of life and posing a risk of severe complications.
Ironwood is hosting a conference call and webcast today to discuss the topline results of the STARS trial. This news is based on a press release statement issued by Ironwood Pharmaceuticals.
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