AstraZeneca, Ironwood Report Positive Top-Line Data From Phase III IBS-C Trial

(RTTNews) - AstraZeneca Pharmaceuticals Co., Ltd. (AZN, AZN.L) and Ironwood Pharmaceuticals, Inc. (IRWD) reported top-line data demonstrating linaclotide met all primary and secondary endpoints, covering multiple abdominal and constipation symptoms, in a Phase III clinical trial of adults with irritable bowel syndrome with constipation or IBS-C.

The trial was conducted primarily in China. The companies intend to file in early 2016 for China Food and Drug Administration approval to market linaclotide.

Linaclotide is currently approved in the U.S. for the treatment of adults with IBS-C or chronic idiopathic constipation and in several other countries for adults with IBS-C.

The double-blind, placebo-controlled Phase III clinical trial randomized 839 adults with IBS-C in China, Australia, Canada, New Zealand and the U.S.

Patients were randomized 1:1 to receive either 290 mcg of linaclotide, or placebo, for 12 weeks. The primary endpoints used in this trial were similar to those previously used to support approval of linaclotide in the European Union.

The co-primary endpoints of the trial were 12-Week Abdominal Pain/Discomfort Responder, and 12-Week IBS Degree of Relief Responder.

Top-line data from the Phase III trial indicate linaclotide-treated patients showed statistically significant improvement compared to placebo-treated patients for both co-primary endpoints.