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ARTICLE | Clinical News

Colonic-release linaclotide: Ph IIb data

January 27, 2017 9:05 PM UTC

Top-line data from a double-blind, U.S. Phase IIb trial in 532 adult patients with IBS-C showed that once-daily 300 µg oral colonic-release-1 formulation of linaclotide (CR1) for 12 weeks led to a greater proportion of APC responders vs. 290 µg oral immediate-release Linzess linaclotide and placebo (38.8% vs. 31.8% and 21.2%, respectively). Responders were defined as achieving a ≥30% reduction in abdominal pain from baseline and an increase of ≥1 CSBM from baseline in the same week for ≥6 out of 12 weeks. Additionally, CR1 led to a mean weekly reduction in abdominal pain from baseline to week 12 of 2.14 points vs. 1.94 points for immediate-release linaclotide and 1.37 points for placebo. Furthermore, CR1 led to a mean weekly change in CSBM frequency from baseline to week 12 of 1.78 vs. 2.11 for immediate-release linaclotide and 1.11 for placebo. CR1 also led to a mean percent reduction in abdominal pain from baseline to week 12 of 49.5% vs. 40.6% for immediate-release linaclotide and 26.2% for placebo.

In patients treated with colonic-release-2 formulation of linaclotide (CR2), once-daily 30, 100 and 300 µg oral CR2 for 12 weeks led to a mean weekly change in Bristol Stool Form Scale (BSFS) scores from baseline to week 12 of 1-1.15 points vs. 0.94 points for placebo. Additionally, CR2 led a mean weekly change in CSBM frequency from baseline to week 12 of 0.87-1.28 vs. 1.11 for placebo. Furthermore, CR2 led to mean weekly reductions in abdominal pain from baseline to week 12 of 1.63-1.83 points vs. 1.37 points for placebo. CR2 also led to a mean percent reduction in abdominal pain from baseline to week 12 of 33.8-36.6% vs. 26.2% for placebo. Next half, Allergan and Ironwood plan to start Phase III testing of CR1 to treat IBS-C. The partners also plan to discuss with FDA next steps for advancing CR2 into a Phase IIb trial to treat patients with non-constipation subtypes of IBS...