Ironwood and Forest Present Positive Linaclotide Results from Two Pivotal Phase 3 Trials in Patients with Chronic Constipation

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today presented Phase 3 clinical trial results assessing the efficacy and safety of the investigational drug linaclotide in patients with chronic constipation (CC). Linaclotide is a guanylate cyclase type C (GC-C) agonist in Phase 3 clinical development for the treatment of irritable bowel syndrome with constipation (IBS-C) and CC. The data presented demonstrate that statistical significance versus placebo was achieved for the primary endpoint of 12-week complete spontaneous bowel movement (CSBM) overall responder for each of the two doses studied in each trial. Statistical significance was also achieved for all secondary endpoints versus placebo, which included measures of bloating, abdominal discomfort, weekly spontaneous bowel movements (SBMs), and weekly CSBMs. Treatment responses occurred within one week and were sustained over the 12-week treatment period. Additional analyses demonstrate that in patients who were switched from linaclotide to placebo during the four-week randomized withdrawal period, constipation symptoms returned toward pretreatment levels, without evidence of worsening compared to baseline (i.e., rebound constipation).

Results were presented today at the Digestive Disease Week (DDW) conference being held in New Orleans from May 1 through May 5, 2010. Top-line results from these trials were previously announced by Ironwood and Forest in a press release on November 2, 2009.

“As many as 34 million people in the U.S.i suffer from chronic constipation and many patients are not fully satisfied with currently available treatments.ii I am encouraged by the results from these Phase 3 trials which show that linaclotide statistically significantly improved each of the constipation and abdominal symptoms measured,” stated investigator Anthony Lembo, M.D., Director, GI Motility Center, Beth Israel Deaconess Medical Center, Boston. “The results of these trials suggest that linaclotide may provide an attractive option for millions of patients suffering from chronic constipation.”

Phase 3 Linaclotide Chronic Constipation Trials

A total of 1,276 patients who met modified Rome II criteria for CC were randomized to receive oral once-daily dosing of linaclotide (133 mcg or 266 mcg) or placebo for 12 weeks in two similarly designed double-blind Phase 3 trials (Trials 01 and 303). Trial 303 also included an additional four-week placebo-controlled randomized withdrawal period, which will be presented as a poster at DDW on Tuesday, May 4, 2010. The average age of the patients was 48 years, 89 percent were female, and 76 percent were Caucasian.

For both trials, the primary endpoint, CSBM overall responder, was defined as a patient achieving three or more CSBMs per week and an increase of at least one CSBM per week from baseline for at least nine of the 12 weeks in the trial. Secondary endpoints were change from baseline in weekly frequency of CSBMs and SBMs, as well as assessments of stool consistency, severity of straining, constipation severity, abdominal discomfort, and bloating. Safety and tolerability were also assessed.

After 12 weeks of treatment, statistically significantly more linaclotide patients met the primary endpoint in each trial compared to placebo. In Trial 01, 16.0 percent of patients receiving 133 mcg of linaclotide and 21.3 percent of patients receiving 266 mcg of linaclotide met the primary endpoint compared to 6.0 percent in the placebo group (p=0.0012 and p

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