Ironwood, AstraZeneca Initiate Linaclotide PhIII Trial In China

Ironwood and AstraZeneca have initiated a Phase III clinical trial of linaclotide for the treatment of adults with irritable bowel syndrome with constipation.

AsianScientist (Sep. 23, 2013) – Ironwood Pharmaceuticals, Inc. 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 (IBS-C).

Linaclotide is currently approved in the United States 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 United States 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.

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.

Under the terms of the collaboration, AstraZeneca made an upfront payment of US$25 million to Ironwood, and the two companies will share the net profits and losses associated with linaclotide in China, with AstraZeneca carrying 55 percent of each until a certain specified milestone is achieved, moving to a 50/50 split thereafter. Ironwood is also eligible for $125 million in additional commercial milestone payments contingent on the achievement of certain sales targets.

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Source: Ironwood Pharmaceuticals, Inc.
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