Ironwood and Allergan Report Positive Topline Data from Phase IIIb Trial of LINZESS (linaclotide) in Adults with Irritable Bowel Syndrome with Constipation (IBS-C) - Seite 2

Linaclotide was well-tolerated in this Phase IIIb study, with the most commonly reported adverse event being diarrhea. During the treatment period, diarrhea was reported in 4.6% of patients on linaclotide 290 mcg as compared to 1.6% of patients on placebo. Study discontinuation resulting from diarrhea occurred in 1.6% of linaclotide 290 mcg patients compared to none of the placebo-treated patients.

“These topline results demonstrated that LINZESS can help provide overall relief of some of the multiple abdominal symptoms that IBS-C patients identify as among the most bothersome,” said Mike Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of drug development at Ironwood. “As the 10^th Phase III trial of linaclotide to meet its primary endpoint, this study further contributes to the robust body of evidence supporting the use of LINZESS in adults with IBS-C and further strengthens its clinical profile.”

“IBS-C is a frustrating and uncomfortable condition, but it can be treated. We expect that communicating the full clinical profile of LINZESS on the overall abdominal symptoms of bloating, pain, and discomfort will broaden physicians’ understanding of the appropriate patient and may help those who need to find relief,” said David Nicholson, chief research & development officer at Allergan.

The randomized, double-blind, placebo-controlled, parallel-group study was designed to evaluate the efficacy and safety of LINZESS 290 mcg on multiple abdominal symptoms in adult patients with IBS-C. 614 patients were randomized to placebo or LINZESS 290 mcg once daily for 12 weeks, followed by a four-week randomized withdrawal period. The primary efficacy endpoint was change from baseline in abdominal score based on daily patient assessments of abdominal bloating, pain and discomfort at their worst, as reported on an 11-point numerical rating scale. Additional endpoints included change from baseline in spontaneous bowel movement frequency, complete spontaneous bowel movement frequency, stool consistency, and straining.

Additional data from this Phase IIIb trial are expected to be shared at upcoming scientific meetings and via peer-reviewed publications.

About Linaclotide

Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is marketed by Ironwood and Allergan plc in the United States as LINZESS and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linaclotide is marketed by Allergan for the treatment of adults with moderate to severe IBS-C in Europe under the brand name CONSTELLA. Ironwood is partnered with AstraZeneca for development and commercialization of linaclotide in China, Hong Kong and Macau. Astellas has the exclusive rights to develop and commercialize linaclotide in Japan. Allergan has rights to develop and market in the remaining rest of world countries.