Phase II Trial for Diarrhea-Predominant Irritable Bowel Syndrome

WALTHAM, Mass. -- Dynogen Pharmaceuticals, Inc. announced that it has initiated a Phase II proof-of-concept trial of DDP225 for diarrhea-predominant irritable bowel syndrome (IBS-d), and the first patients have been dosed. DDP225 is an orally-active compound that targets two key pathways that control the gastrointestinal (GI) system, thus giving it the potential to address multiple symptoms associated with IBS-d. This trial is a randomized, double-blind, placebo controlled study that is enrolling patients with IBS-d at multiple centers in Canada and is assessing safety and pharmacodynamic efficacy as well as symptom-based endpoints. In September 2005, Dynogen began dosing patients in a Phase II study of DDP733 for the treatment of patients with constipation-predominant IBS (IBS-c), the other common form of IBS.

"DDP225 is a unique and very promising compound because of its dual mechanism of action," said Suhail Nurbhai, MRCP, vice president of Clinical Development at Dynogen. "It possesses both noradrenaline reuptake inhibition and 5-HT3 receptor antagonist properties. We are particularly excited about the potential for DDP225 for the treatment of IBS-d because this two-pronged attack may yield significant advantages in addressing the multi-symptomatic nature of a disorder that has proven difficult to treat."

About DDP225
DDP225 is both a noradrenaline reuptake inhibitor and a serotonin type 3 receptor (5-HT3) 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 5-HT3 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 Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome is a chronic condition that is believed to be caused by the abnormal function (dysfunction) of the muscles and/or nerves of the organs of the GI tract. Patients with IBS experience abdominal pain, discomfort and bloating accompanied by altered bowel habit that can include either diarrhea, constipation or both. IBS has prevalence of up to 12 percent of the general population and females under the age of 45 account for 80 percent of the patient population with severe cases. It is the most common disease diagnosed by gastroenterologists and one of the most common disorders seen by primary care physicians.

About Dynogen Pharmaceuticals, Inc.
Dynogen is a privately held, neuroscience-based pharmaceutical company developing more effective treatments for genitourinary and gastrointestinal disorders. Today, Dynogen has three clinical development candidates, DDP200 for overactive bladder, DDP225 for diarrhea-predominant irritable bowel syndrome (IBS-d) and chronic functional vomiting (CFV), and DDP733 for constipation-predominant IBS (IBS-c) and nocturnal gastroesophageal reflux disease (NGERD).

Source: Dynogen Pharmaceuticals, Inc.