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

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE:AGN) today announced positive topline data from a Phase IIIb clinical trial evaluating LINZESS (linaclotide) 290 mcg on multiple abdominal symptoms in adult patients with IBS-C. The trial met its primary multi-component endpoint and demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adult IBS-C patients compared to placebo. The trial also met both secondary endpoints. This trial was designed to highlight the impact of LINZESS on the overall abdominal symptoms of bloating, pain and discomfort, which are part of patients’ reported real-world experience, thereby enabling better communication about these symptoms.

LINZESS is marketed by Ironwood and Allergan in the United States and is indicated for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC). Research has shown that approximately 95 percent of adults with IBS-C experience bothersome abdominal bloating, pain, and/or discomfort, with the majority experiencing these symptoms once a week or more. There are an estimated 13 million adults in the U.S. with IBS-C.^1,2

“While research clearly suggests that the symptoms of abdominal bloating, pain, and discomfort have a considerable impact on adults suffering from IBS-C, in the clinical setting patients often use the word ‘constipation’ as a general term to represent their abdominal and bowel symptoms. This can lead to a less precise communication regarding their symptoms between patient and physician and can impact management,” said Lin Chang, M.D., Professor of Medicine at the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California, Los Angeles (UCLA). “I believe the data from this LINZESS Phase IIIb trial will be very important in helping patients and physicians have a more comprehensive dialogue about the multiple symptoms associated with IBS-C.”

Topline data from a randomized, double-blind, placebo-controlled Phase IIIb trial showed that linaclotide 290 mcg administered orally once daily demonstrated a statistically significant and clinically meaningful improvement in overall abdominal symptoms compared to placebo across the primary and both secondary endpoints. In the multi-component primary endpoint, linaclotide-treated patients showed a 29.7% mean decrease from baseline in their weekly abdominal score (bloating, pain and discomfort) through the 12-week treatment period, compared to 18.3% for the placebo-treated patients (p<0.0001). In the secondary endpoints, 40.5% of patients treated with linaclotide 290 mcg demonstrated a clinically meaningful response, as defined by the abdominal symptom score responder, compared to 23.4% of placebo-treated patients (p<0.0001). An abdominal symptom score responder was defined as a patient who experienced an improvement of at least two-points from baseline in their weekly abdominal score for at least six of 12 weeks of treatment period. These findings add to the significant body of data supporting the impact of linaclotide on the overall abdominal symptoms of bloating, pain and discomfort in adult IBS-C patients.