(RTTNews) - Ironwood Pharmaceuticals, Inc. and Forest Lab., Inc. (FRX: News ) said Monday that once-daily dosing of their investigational drug linaclotide for chronic constipation showed positive top-line results in two Phase 3 clinical trials assessing the safety and efficacy of the drug.

The two, multicenter, randomized, double-blind, placebo-controlled trials are part of larger Phase 3 program investigating the effect of linaclotide treatment on patients with chronic constipation or irritable bowel syndrome with constipation, or 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.

Trial 01, a 12 week trial conducted in 633 patients meeting modified Rome II criteria for chronic constipation. Trial 303 enrolled 643 patients, with identical design, but for an additional four-week randomized withdrawal period.

Data analyses showed that both trials met primary and all secondary endpoints. Each trial demonstrated statistically significant level of complete spontaneous bowel movement, or CSBM overall responder, which is the primary endpoint, as well as achieved all pre-specified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs.

Across both trials, the most common adverse events were diarrhea, flatulence, and abdominal pain. Due to adverse events, discontinuation in linaclotide-treated patients was 7.4% for and 4.2% for placebo.

Chronic constipation, or CC, is characterized by strained defecation, incomplete evacuation, and fewer than three bowel movements per week, as well as discomfort and bloating. Around 34 million Americans suffer from CC symptoms.
IBS-C is a chronic functional gastrointestinal disorder characterized by abdominal pain, discomfort, and bloating associated with altered bowel habits, and as many as 11 million people in the US suffer from it.

Linaclotide, a first-in-class compound in development for the treatment of IBS-C and CC, is an agonist of guanylate cyclase type-C (GC-C), a receptor found on the lining of the intestine. Linaclotide is an orally delivered peptide that acts locally in the gut. Composition of matter patent for linaclotide provides protection to 2025.

In September 2007, Ironwood and Forest entered into a 50/50 collaboration to co-develop and co-promote linaclotide in the US. In April, Ironwood licensed the European rights to develop and commercialize linaclotide to Almirall.

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