US-based Synergy Pharmaceuticals has begun the first of two planned Phase III clinical studies to confirm the safety and efficacy of its lead GC-C agonist and once-daily oral treatment ‘plecanatide’, in adult patients with chronic idiopathic constipation (CIC).
The randomised, double-blind, clinical trial is designed to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients with CIC.
Around 1,350 patients with CIC will be enrolled in the trial, which will be carried out at about 180 sites in the US and Canada.
The primary endpoint of the trial is the proportion of patients who are overall responders for the 12-week treatment period.
Synergy Pharmaceuticals chief executive officer Gary Jacob said plecanatide has already showed a favourable safety and efficacy profile in a recently completed large, multi-center study in 951 patients with CIC.
"We look forward to further evaluating the effect of plecanatide in CIC patients and believe it is well positioned to be the best-in-class GC-C agonist with superior pharmacologic properties that support a very unique tolerability profile," Jacob said.
In the US, 45 million people, suffer from chronic constipation that affects both men and women of every age, with a similar prevalence in other developed countries.
Chronic constipation disproportionately impacts women and the elderly, which is a large and growing population.
According to the company, current treatments offer temporary relief, but because they fail to address the underlying causes of chronic constipation, they do not normalise patients’ bowel function and such treatments are also related with unpleasant side effects, the most common of which is diarrhoea, causing patients to see-saw between extremes.
As a result, most doctors and their patients are dissatisfied with current treatments for chronic constipation.
Plecanatide is currently being developed to treat patients with CIC and irritable bowel syndrome with constipation (IBS-C).
At the start of this year, Synergy announced positive results from a large multicentre trial of plecanatide in patients with CIC and later completed an end-of-Phase II meeting with the US Food and Drug Administration in July 2013 covering the registration program for plecanatide to treat CIC.
The company plans to announce topline data results from its ongoing Phase IIb study of plecanatide in IBS-C patients in the first quarter of 2014.