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Phase 3 trial of linaclotide for IBS-C meets primary endpoints in Japan
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Linaclotide improved symptoms and increased complete spontaneous bowel movements in adults with constipation-predominant irritable bowel syndrome in a phase 3 Japanese clinical trial, the manufacturer announced.
In light of these results, Astellas anticipates it will submit a new drug application for linaclotide to the Ministry of Health, Labor and Welfare in Japan next year, according to a press release. Linaclotide, a guanylate cyclase-C agonist, is approved in the U.S. for IBS-C and chronic idiopathic constipation (Linzess, Ironwood), and in more than 30 additional countries.
“Linaclotide has now met all primary endpoints in all eight of its phase 3/3b clinical trials, spanning two indications, three doses and multiple countries,” Mark Currie, PhD, chief scientific officer and president of research and development at Ironwood, said in a press release. “Our recent positive phase 3 data in China and now in Japan represent important achievements by Ironwood and our global partners toward bringing linaclotide to appropriate patients around the world, and we continue to innovate with linaclotide as part of our mission to address a broad spectrum of patient needs.”
In this double-blind, placebo-controlled trial, 500 IBS-C patients were randomly assigned to receive 500 µg linaclotide or placebo for 12 weeks. Global symptom relief response rate for at least 6 of the 12 weeks and complete spontaneous bowel movement response rate (at least three per week and at least one per week increase from baseline for at least 6 of the 12 weeks) served as co-primary endpoints.
Overall, 34% of the treatment group were global symptom relief responders vs. 18% of the placebo group, while 35% vs. 19% were complete spontaneous bowel movement responders (both P < .001). Abdominal and constipation symptoms also improved, and mild-to-moderate diarrhea occurred in 9.6% of the treatment group vs. 0.4% of the placebo group. A 40-week, open-label, follow-up is currently ongoing, according to the press release.
“I am really pleased to receive the positive top-line data from the phase 3 IBS-C trial,” Bernhardt G. Zeiher, MD, president of development at Astellas Group, said in the press release. “Astellas expects linaclotide to provide a new therapeutic option for patients suffering from IBS-C.”
Disclosures: Currie reports he is an employee of Ironwood. Zeiher reports he is an employee of Astellas.