Updated on 11 September 2013
IBS-C is estimated to affect at least 13 million adults in China, causing hallmark symptoms such as abdominal pain and constipation
Singapore: Ironwood Pharmaceuticals and AstraZeneca Pharmaceuticals have announced the initiation of a phase III clinical trial of linaclotide in China for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Linaclotide that is currently approved in the United States for adults with IBS-C or chronic idiopathic constipation (CIC), is also approved 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. 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," said Mr David Snow, president, AstraZeneca China in a press statement.
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 United States and European Union. Patients will be randomized 1:1 to receive either 290mcg of linaclotide or placebo for 12 weeks.
Both the companies 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.