Ironwood Pharmaceuticals Announces Positive Results from its Phase II Exploratory STARGAZE Trial of Apraglutide in Patients with Steroid-Refractory Gastrointestinal Acute Graft-versus-Host Disease (SR GI aGVHD) - Seite 2

“These results from the first-of-its-kind STARGAZE trial in a population of patients with SR GI aGVHD add to the body of evidence about the safety and tolerability profile of apraglutide,” said Michael Shetzline, M.D., Ph.D., Senior Vice President, Chief Medical Officer and Head of Research and Development at Ironwood Pharmaceuticals. “Other studies have shown that GLP-2 promotes intestinal healing and regeneration, and we look forward to further understanding the data from this trial given the high unmet medical need of these patients who suffer from high morbidity and mortality.”

Additional data from the STARGAZE trial are expected to be presented at an upcoming medical congress. The STARGAZE study will continue through its two-year endpoint, where apraglutide will be re-evaluated for safety and efficacy.

About STARGAZE

STARGAZE (Study of Apraglutide in Graft-versus-Host Disease) is a randomized, single-blind, Phase II exploratory trial designed to evaluate weekly dosing of apraglutide in combination with standard of care, including systemic corticosteroids and ruxolitinib in patients with steroid-refractory GI aGVHD for up to 90 days with a follow-up period lasting up to two years after the first dose. STARGAZE is the first prospective trial of a glucagon-like peptide (GLP-2) analog focusing on patients with steroid-refractory GI aGVHD. The trial enrolled 31 patients and at this primary analysis, evaluated them for safety and tolerability, pharmacokinetics, and efficacy, including response rate, duration of response, and survival-related outcomes. This study’s population consisted of more than 87% Grade III and IV patients, the most severe cohort as measured by the Mount Sinai Acute Graft Versus Host Disease International Consortium (MAGIC) scale.

About Acute Graft-Versus-Host Disease (aGVHD)

Acute Graft-Versus-Host Disease (aGVHD) is a severe condition which occurs when immune cells from the donor attack a recipient’s healthy cells after an allogeneic hematopoietic stem cell transplant (HSCT), the standard last-line treatment for many forms of blood cancer. aGVHD typically emerges within the first 100 days post-transplant and predominantly affects the skin, gastrointestinal (GI) tract and liver. GI GvHD is one of the leading causes of morbidity and mortality following HSCT. The predominant manifestations of GI GVHD are abdominal pain and diarrhea. The diarrhea is secretory, occurs independently of oral intake and can be profound and incessant, with up to several liters of output and more than 10 episodes per day, often requiring parenteral support to feed and hydrate patients. More than 26,000 allogeneic HSCTs take place in the U.S., Europe and Japan annually and aGVHD occurs in an estimated 30-50% of patients. While treatment options exist for aGVHD, a significant number of patients do not respond to 1^st line therapy, such as corticosteroids. Despite receiving 2^nd line therapy, many patients also do not maintain response over time, with significant non-relapse mortality (NRM) after six months.