Top-line results from Phase 3 linaclotide trial for chronic constipation

Nov 3 2009

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC). Analyses of the data indicate that in both multicenter, randomized, double-blind, placebo-controlled trials, statistical significance was achieved for the primary endpoint of 12-week complete spontaneous bowel movement (CSBM) overall responder at the two doses studied in each trial (133 mcg/day: p-values≤0.0012 and 266 mcg/day: p-values<0.0001). In both trials, statistical significance (p<0.01) was achieved for all prespecified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs.

“The results of these two trials confirm the potential for linaclotide to bring relief to the millions of patients suffering from many of the symptoms associated with chronic constipation,” said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. “These outcomes are the result of outstanding collaboration between Ironwood and Forest, with both companies participating in these clinical trials. We look forward to further advancing the development of linaclotide, a novel product in a therapeutic category where patients have very limited treatment options.”

Peter Hecht, Chief Executive Officer of Ironwood, said, “We are very pleased to observe how well the top-line results of these larger Phase 3 trials replicate the effect of linaclotide observed in our Phase 2b trial.”

These two trials are part of Ironwood and Forest’s larger Phase 3 program investigating the effect of linaclotide treatment on patients with CC or irritable bowel syndrome with constipation (IBS-C). The companies are currently enrolling two additional pivotal Phase 3 trials in North America to assess the safety and efficacy of linaclotide in patients with IBS-C and expect results in the second half of calendar year 2010.

SOURCE Ironwood Pharmaceuticals