Dynogen Initiates Phase II Trial of DDP225 for Treatment of Chronic Functional Vomiting
Dynogen Pharmaceuticals, Inc. announced today that it has initiated a Phase II trial of DDP225 in patients with chronic functional vomiting (CFV) and the first patients have been dosed. This Phase II trial is a randomized, double-blinded, placebo controlled study that is assessing multiple symptom-based endpoints. The trial is being conducted at multiple U.S. sites. CFV is the second clinical indication for DDP225, an orally-active compound that targets two key pathways that control the gastrointestinal (GI) system. Dynogen initiated a Phase II trial for DDP225 in patients with diarrhea-predominant irritable bowel syndrome (IBS-d) in October 2005.
“DDP225 represents a novel and potentially the first treatment option for patients suffering from CFV. This unique study is designed to both validate efficacy and lay the pathway for a rapid product registration trial,” said Lee R. Brettman, M.D., Chief Executive Officer at Dynogen. “We now have three Phase II programs underway for the treatment of gastrointestinal disorders and we expect to have the data from these trials in early 2007,” added Brettman.
“DDP225 is unique because it possesses two mechanisms of action. It is both a noradrenaline reuptake inhibitor and a 5-HT(3) receptor antagonist, and each of these modes of action is known to have positive effects in the treatment of GI disorders,” said Dr. Suhail Nurbhai, MRCP, Vice President of Clinical Development at Dynogen. “By targeting two important mechanisms with one compound, we believe that we can use a low dose to achieve the desired therapeutic benefit while at the same time minimizing the risk of side effects.”
About DDP225
DDP225 is both a noradrenaline reuptake inhibitor and a serotonin type 3 receptor (5-HT(3)) antagonist. Noradrenaline and serotonin are neurotransmitters that are known to be involved in the control of the gastrointestinal system. The unique combination of noradrenaline reuptake inhibition and serotonin antagonism in one orally delivered compound represents a novel approach to treating IBS-d and other functional GI diseases. Dynogen licensed preclinical and clinical data related to DDP225 from Mitsubishi Pharma in October 2003.
About Chronic Functional Vomiting (CFV)
Chronic functional vomiting is a chronic condition that is believed to be caused by the abnormal function (dysfunction) of the muscles or nerves controlling the organs of the middle and upper gastrointestinal (GI) tract. Patients with CFV experience abdominal pain, nausea and recurrent vomiting in the absence of known medical and psychiatric causes. There are no drugs specifically approved to treat the disease.
About Dynogen Pharmaceuticals, Inc.
Dynogen is a privately held pharmaceutical company developing more effective treatments for gastrointestinal and genitourinary disorders. Today, Dynogen has three clinical development candidates, DDP225 for irritable bowel syndrome with diarrhea (IBS-d) and chronic functional vomiting (CFV), and DDP733 for IBS with constipation (IBS-c) and nocturnal gastroesophageal reflux disease (n-GERD) and DDP200 for overactive bladder. More information about the Company can be found by visiting our website www.dynogen.com.