Synergy Pharmaceuticals to Present Phase I Volunteer Study on SP-304 Investigational Drug to Treat GI Disorders at Upcoming Conference
Data to be Presented at Digestive Disease Week 2009 Conference
The poster presentation entitled: “A Randomized, Double-blind, Placebo-Controlled, Single-, Ascending-, Oral-Dose Safety, Tolerability and Pharmacokinetic Study of SP-304 in Healthy Adult Human Male and Female Volunteers” by Kunwar Shailubhai, Ph.D., William A. Gerson, D.O., Craig Talluto, Ph.D. and G.S. Jacob, Ph.D. will be on Wednesday, June 3 from 8:00 am to 5:00 pm in the South Hall (McCormick Place).
SP-304 is a member of a new class of non-systemic drugs for treatment of chronic constipation (CC), irritable bowel syndrome with constipation (IBS-C) and other GI diseases. SP-304 is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered SP-304 binds to and activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator (CFTR), and leading to augmented flow of chloride and water into the lumen of the gut, facilitating bowel movement. In animal models, oral administration of SP-304 promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.
About Irritable Bowel Syndrome
Up to one sixth of adults experience inflammatory bowel syndrome (IBS), a condition marked by disturbed bowel function and abdominal pain. IBS patients can have three different sets of symptoms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and mixed or alternating disorder (IBS-M). The split in prevalence between the forms is about 1/3rd each. In addition, most patients suffering from the mixed form of IBS (IBS-M) are believed to mainly have constipation. An estimated 10 million people in the US and an additional 10 million people in the EU suffer from IBS-C. IBS (all forms) accounts for 12% of adult visits to primary care physicians in the US.
About Chronic Constipation
Chronic constipation is a very common gastrointestinal disorder. Up to 26 million Americans suffer from the disorder, and of this population about 5 million have a severe condition necessitating relief. The prevalence of the disorder is similar in other developed countries. Patients with chronic constipation often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with chronic constipation can experience serious discomfort which adversely affects their ability to work and their quality of life.
About Synergy Pharmaceuticals, Inc.
Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy's proprietary drug SP-304 began clinical development in June 2008 for gastro-intestinal disorders. SP-304 recently finished a Phase I clinical trial in volunteers and the Company plans to initiate a Phase IIa clinical trial of SP-304 in chronic constipation patients in late 2009 or early 2010. SP-304 is a synthetic analog of the human gastrointestinal hormone uroguanylin, and acts by activating the guanylate cyclase C (GC-C) receptor on epithelial cells of the GI tract.
Posted: May 2009