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Results presented at Digestive Disease Week 2008
WALTHAM, MA, USA | May 20, 2008 | Dynogen Pharmaceuticals, Inc. announced today the presentation of positive results from its Phase 2a clinical trial for DDP733 (pumosetrag) as a treatment for irritable bowel syndrome with constipation (IBS-c) at the Digestive Disease Week 2008 (DDW) scientific meeting. The randomized, double-blind, placebo controlled, parallel group study established clinical proof-of-concept and demonstrated a statistically significant improvement over placebo in the endpoint of overall subject global assessment (OSGA) of IBS. The drug candidate was also well-tolerated.
Dynogen previously reported top-line results from this Phase 2a trial in February 2007. The DDW abstract was co-authored by Dynogen and a team of investigators from leading clinical centers in Canada.
DDP733 is an oral prokinetic drug which Dynogen is developing as a treatment for both IBS-c and nocturnal gastroesophageal reflux disease (NGERD). In the Phase 2a IBS-c study, 91 patients were randomized in a double-blind fashion to one of five treatment groups (placebo, 0.2, 0.5, 0.8 or 1.4 mg) and study medication was administered three times per day for 28 days. Patients used a diary to record their overall global assessment of relief of IBS, as well as data related to specific IBS symptoms, study medication, rescue medication use, and adverse events. DDP733 achieved a statistically significant benefit in the protocol defined clinical endpoint of overall relief of IBS as measured by OSGA with 54% of subjects in the 1.4 mg dose group responding to treatment compared to 15% of subjects in the placebo group (p=0.039). No other treatment groups were statistically different from placebo. Consistent improvements in the individually recorded symptoms supported overall efficacy. A pharmacodynamic
assessment of gastrointestinal transit was included in the study, but did not yield interpretable results.
DDP733 was safe and well-tolerated in this study.
“We believe the strong clinical efficacy and good safety profile will clearly differentiate DDP733 from other drugs for IBS-c,” said Dr. Suhail Nurbhai, MRCP, Vice President of Clinical Development at Dynogen. “DDP733 represents a valuable opportunity to provide a new therapeutic option for a poorly served patient population, and presenting these results at DDW underlines the potential of this program.”
“With limited treatment options available to those suffering from IBS-c, there is a tremendous need for safe and efficacious alternatives to address the debilitating symptoms that affect these patients,” said Dr. William Paterson, M.D., Chief of the Division of Gastroenterology at Queen’s University in Kingston, Ontario. “DDP733 is a first-in-class treatment for IBS-c, and these clinical data look very promising. I look forward to seeing the results from future studies with this compound.”
About DDP733
DDP733 is an oral, minimally absorbed, partial agonist of the 5-HT3 receptor. In addition to the IBS-c program, Dynogen announced results from a Phase 1b translational medicine gastroesophageal reflux study of DDP733 in June 2007. In that study, DDP733 achieved statistical significance over placebo on the primary endpoint of reduction in the number of reflux events. The drug was safe and well–tolerated in both studies. Dynogen initiated a Phase 2b study of DDP733 in IBS-c patients in November 2007.
About Irritable Bowel Syndrome (IBS)
IBS affects approximately 12% of the U.S. population, or 27 million individuals. IBS is a chronic disease characterized by abdominal pain and discomfort associated with altered bowel habit. IBS is associated with $1.6 billion in direct medical costs and $19.2 in indirect costs in the U.S. each year.
Patients with IBS make an average of 5.5 visits to the physician each year compared to 1.9 visits annually for people without bowel symptoms. Additionally, people with IBS incur healthcare costs nearly 50% higher than the average American, and miss three times as many days of work.
About Digestive Disease Week
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San
Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
About Dynogen Pharmaceuticals, Inc.
Dynogen is a clinical-stage company developing a portfolio of treatments for gastrointestinal and genitourinary disorders. The Company is focused on large and untapped markets in disease areas that severely impair a patient’s quality of life, such as irritable bowel syndrome, gastroesophageal reflux disease and overactive bladder. The Company leverages its development expertise to identify promising clinical compounds and rapidly advance them towards registration www.dynogen.com
SOURCE: Dynogen Pharmaceuticals, Inc. |
