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November 30, 2015
16:09 EDTIRWDIronwood, Astellas say Phase 3 linaclotide trial in Japan met primary endpoints
Astellas Pharma (ALPMY) and Ironwood Pharmaceuticals (IRWD) announced that the Phase 3 clinical trial of linaclotide conducted in Japan in adults with irritable bowel syndrome with constipation met its primary endpoints. Astellas expects to submit a new drug application to the Ministry of Health, Labor and Welfare in Japan in 2016, the company noted. Top-line data from the trial indicate linaclotide-treated patients showed "statistically significant" improvement compared to placebo-treated patients for both of the two co-primary endpoints. Regarding the first primary endpoint, 34% of linaclotide-treated patients were so-called Global Assessment of Relief of IBS Symptoms Responders, compared to 18% of placebo-treated patients. Regarding the second primary endpoint, 35% of linaclotide-treated patients were Complete Spontaneous Bowel Movement Overall Responders, compared to 19% of placebo-treated patients. Additionally, improvements were achieved in pre-specified secondary endpoints in the trial covering abdominal and constipation symptoms, including bloating and abdominal pain. Diarrhea rates in the trial were 9.6% for linaclotide versus 0.4% for placebo.
08:02 EDTIRWDIronwood says Phase II Linaclotide trial data 'positive'
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