Ironwood and AstraZeneca initiate Phase III IBS-C trial in China
Sep 20, 2013 (MarketLine via COMTEX) --
Ironwood Pharmaceuticals, Inc., a pharmaceutical company engaged in the science and treatment of gastrointestinal diseases, and AstraZeneca Pharmaceuticals Co., Ltd. have initiated a Phase III clinical trial of linaclotide for the treatment of adults with irritable bowel syndrome with constipation, or IBS-C, in China.
Linaclotide is currently approved in the US for adults with IBS-C or chronic idiopathic constipation (CIC) and in the European Union for adults with moderate to severe IBS-C.
"IBS-C is estimated to affect at least 13 million adults in China, causing hallmark symptoms such as abdominal pain and constipation," said David Snow, President of AstraZeneca China. "If approved in China, linaclotide could be the first prescription treatment specifically for IBS-C and could then help address an unmet need for millions of suffering patients."
The double-blind, randomized, placebo-controlled Phase III clinical trial is expected to enroll approximately 800 adults with IBS-C in China, Australia and New Zealand. The design of the trial is similar to the 12-week Phase III IBS-C trial that supported linaclotide regulatory approval in the US and European Union. Patients will be randomized 1:1 to receive either 290mcg of linaclotide or placebo for 12 weeks. The co-primary endpoints of the trial are (i) Abdominal Pain/Discomfort Responder at 12 weeks, which is defined in the study protocol as a patient who has at least a 30 percent improvement in his/her abdominal pain/discomfort level for at least half of the treatment period, and (ii) IBS Degree of Relief Responder at 12 weeks, which is defined in the study protocol as a patient who is considerably or completely relieved of symptoms for at least half of the treatment period.
Ironwood and AstraZeneca anticipate the availability of top-line data in the first half of 2015 and, if approved by the China Food and Drug Administration (CFDA), anticipate that linaclotide could be commercialized in China in 2017.
"Linaclotide is approved in the US and in the European Union, and the initiation of this Phase III trial is a critical step along the regulatory pathway to support approval in China. We continue to make strides toward our goal of bringing linaclotide to appropriate adult patients around the world, and we look forward to continuing to collaborate with AstraZeneca to serve the unmet needs of patients in China," said Mark Currie, Ph.D., senior vice president, chief scientific officer, and president of R&D at Ironwood.
Based on a collaboration announced in October 2012, Ironwood and AstraZeneca are jointly responsible for the development and commercialization of linaclotide in China, with AstraZeneca primarily responsible for local operational execution.
Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical models. Linaclotide binds to guanylate cyclase-C locally in the intestine, resulting in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP).
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