Once-Weekly Apraglutide Showed Consistent Treatment Effect Across Baseline Demographics and Disease Characteristics in Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF), According to New STARS Phase III Data from Ironwood at ACG 2024

– New safety and tolerability data show high treatment compliance with apraglutide, low incidence of injection site reactions and adverse events associated with GI tolerability –

– Findings reinforce the clinical profile of once-weekly apraglutide; Ironwood expects to complete U.S. regulatory submission in Q1 2025 –

– One apraglutide poster recognized as presidential poster recipient –

– New linaclotide data shed light on treatment outcomes across patient demographics –

BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, will present new findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting and Postgraduate Course from subgroup analyses of the primary endpoint of the pivotal Phase III clinical trial, STARS, evaluating the treatment effect of apraglutide by baseline demographics and disease-specific characteristics in adults with short bowel syndrome with intestinal failure (SBS-IF). The data, which will be unveiled during an oral presentation tomorrow, October 29, from 8:30 am – 8:40 am ET, indicate that apraglutide showed a consistent treatment effect across subgroups: gender, age, body weight, region, race, ethnicity and SBS characteristics – including length of remnant bowel. These findings build on previously announced positive data from the phase III pivotal trial.

SBS-IF, a rare chronic debilitating malabsorptive condition in which patients are dependent on parenteral support (PS), affects an estimated 18,000 adult patients in the U.S., Europe and Japan. Apraglutide is the first and only investigational once-weekly GLP-2 analog that has successfully demonstrated positive results in a Phase III placebo-controlled study. Ironwood is working to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and marketing applications to other regulatory agencies for apraglutide for the treatment of adult patients with SBS who are dependent on PS.

STARS represents the largest Phase III trial in SBS-IF conducted to date, and the only study that pre-specified patient stratification based on remnant bowel anatomy. Ironwood previously reported that the STARS clinical trial met its primary endpoint of relative change from baseline in actual weekly PS volume at week 24 vs. placebo (-25.5% vs. -12.5%; p=0.001). The new subgroup analyses examined the primary endpoint by demographics for the overall population, which included patients with stoma and colon-in- continuity: gender, age (