NEW YORK, NY, USA I November 13, 2013 I Synergy Pharmaceuticals Inc. (SGYP) today announced the start of the first of two planned phase 3 clinical trials to confirm the safety and efficacy of plecanatide, its lead GC-C agonist and once-daily oral treatment, in adult patients with chronic idiopathic constipation (CIC).
The pivotal phase 3 trial is a randomized, double-blind, clinical trial to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients with CIC. The study will be conducted at approximately 180 sites in the United States and Canada and will enroll approximately 1350 patients with CIC. The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.
“Plecanatide has already demonstrated a favorable safety and efficacy profile in a recently completed large, multi-center study in 951 patients with CIC,” said Dr. Gary S. Jacob, Chief Executive Officer of Synergy Pharmaceuticals Inc. “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.”
About Chronic Idiopathic Constipation
Chronic constipation is the most common digestive complaint worldwide. About 15%, or 45 million people, suffer from chronic constipation in the U.S., with a similar prevalence in other developed countries. Although chronic constipation affects both men and women of every age, it disproportionately impacts women as well as the elderly, a large and growing population.
Current treatments provide temporary relief, but because they fail to address the underlying causes of chronic constipation, they do not normalize patients’ bowel function. Such treatments are also associated with unpleasant side effects, the most common of which is diarrhea, causing patients to see-saw between extremes. As a result, most doctors and their patients are dissatisfied with current treatments for chronic constipation.
About Plecanatide
Plecanatide is Synergy’s lead guanylate cyclase-C (GC-C) agonist in development to treat patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a synthetic analog of uroguanylin, a naturally occurring human GI hormone and physiological agonist of the GC-C receptor. Orally administered plecanatide mimics uroguanylin’s natural activity, binding to and activating the GC-C receptor expressed in the GI tract, resulting in fluid secretion and normalization of bowel movement. In early 2013, Synergy announced positive results from a large multicenter trial of plecanatide in patients with CIC and completed an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) in July covering the registration program for plecanatide to treat CIC. Synergy plans to announce topline data results from its ongoing phase 2b study of plecanatide in IBS-C patients in 1Q2014.
About Synergy Pharmaceuticals Inc.
Synergy Pharmaceuticals is a biopharmaceutical company focused on the development of new drugs to treat patients with gastrointestinal (GI) diseases and disorders. Synergy’s second GC-C agonist, SP-333, is in clinical development to treat opioid-induced constipation (OIC) and ulcerative colitis (UC). SP-333 has successfully completed phase I single and multiple ascending dose studies in healthy volunteers and is currently in a phase 2 clinical trial for OIC. More information is available at www.synergypharma.com.
SOURCE: Synergy Pharmaceuticals
Post Views: 249
NEW YORK, NY, USA I November 13, 2013 I Synergy Pharmaceuticals Inc. (SGYP) today announced the start of the first of two planned phase 3 clinical trials to confirm the safety and efficacy of plecanatide, its lead GC-C agonist and once-daily oral treatment, in adult patients with chronic idiopathic constipation (CIC).
The pivotal phase 3 trial is a randomized, double-blind, clinical trial to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients with CIC. The study will be conducted at approximately 180 sites in the United States and Canada and will enroll approximately 1350 patients with CIC. The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.
“Plecanatide has already demonstrated a favorable safety and efficacy profile in a recently completed large, multi-center study in 951 patients with CIC,” said Dr. Gary S. Jacob, Chief Executive Officer of Synergy Pharmaceuticals Inc. “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.”
About Chronic Idiopathic Constipation
Chronic constipation is the most common digestive complaint worldwide. About 15%, or 45 million people, suffer from chronic constipation in the U.S., with a similar prevalence in other developed countries. Although chronic constipation affects both men and women of every age, it disproportionately impacts women as well as the elderly, a large and growing population.
Current treatments provide temporary relief, but because they fail to address the underlying causes of chronic constipation, they do not normalize patients’ bowel function. Such treatments are also associated with unpleasant side effects, the most common of which is diarrhea, causing patients to see-saw between extremes. As a result, most doctors and their patients are dissatisfied with current treatments for chronic constipation.
About Plecanatide
Plecanatide is Synergy’s lead guanylate cyclase-C (GC-C) agonist in development to treat patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a synthetic analog of uroguanylin, a naturally occurring human GI hormone and physiological agonist of the GC-C receptor. Orally administered plecanatide mimics uroguanylin’s natural activity, binding to and activating the GC-C receptor expressed in the GI tract, resulting in fluid secretion and normalization of bowel movement. In early 2013, Synergy announced positive results from a large multicenter trial of plecanatide in patients with CIC and completed an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) in July covering the registration program for plecanatide to treat CIC. Synergy plans to announce topline data results from its ongoing phase 2b study of plecanatide in IBS-C patients in 1Q2014.
About Synergy Pharmaceuticals Inc.
Synergy Pharmaceuticals is a biopharmaceutical company focused on the development of new drugs to treat patients with gastrointestinal (GI) diseases and disorders. Synergy’s second GC-C agonist, SP-333, is in clinical development to treat opioid-induced constipation (OIC) and ulcerative colitis (UC). SP-333 has successfully completed phase I single and multiple ascending dose studies in healthy volunteers and is currently in a phase 2 clinical trial for OIC. More information is available at www.synergypharma.com.
SOURCE: Synergy Pharmaceuticals
Post Views: 249
