Ironwood Pharmaceuticals and Forest Laboratories have 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.
In the trial, the 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.
The trial showed that the 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 randomised withdrawal period, constipation symptoms returned toward pretreatment levels, without evidence of worsening compared to baseline (i.e., rebound constipation).
Anthony Lembo, investigator of the trial, said: “I am encouraged by the results from these Phase 3 trials which show that Linaclotide improved each of the constipation and abdominal symptoms measured. The results of these trials suggest that Linaclotide may provide an attractive option for patients suffering from chronic constipation.”