Biopharmaceutical company Synergy Pharmaceuticals has reached more than half of the enrolment target in Phase IIb trial of guanylate cyclase-C agonist, Plecanatide, in patients with irritable bowel syndrome with constipation (IBS-C).
More than 600 patients were screened and 180 have been enrolled to date in the study, which is scheduled to complete enrolment of 350 subjects in the fourth quarter of 2013.
Administered once each day for a 12-week period, four doses of plecanatide 0.3mg, 1.0mg, 3.0mg and 9.0mg, along with a placebo arm, are included in the trial.
The trial is entitled ‘A randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation’.
Patients involved in the trial should meet modified Rome III criteria for IBS-C, which includes abdominal pain or discomfort for at least three days in the last three months with symptom onset for at least six months.
In addition, the criteria for the IBS-C subtype must also be met and is further characterised by stool pattern such that more than or equal to 25% of defecations are hard or lump stools and less than or equal to 25% of defecations are loose or watery stools.
Baseline patients with a minimum of three days every week with pain scores greater than or equal to three on a zero to ten scale are involved in pre-treatment.
The study will measure the mean change in CSBMs over the treatment period of 12 weeks compared with patient’s baseline weekly CSBM rate established during the screening phase.
Further assessment includes spontaneous bowel movements and daily abdominal pain, discomfort and bloating scores, as well as the impact of plecanatide on disease-specific quality of life measures.
Topline data from the study, which is being conducted in the US and scheduled to include 350 IBS-C patients, is expected in the first quarter of 2014.