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Dynogen Pharmaceuticals, Inc. to Present Positive Clinical Data for DDP225 and DDP733


4/30/2008 6:35:17 AM

WALTHAM, Mass.--(BUSINESS WIRE)--Dynogen Pharmaceuticals, Inc. announced today that it will present data from the Company’s two irritable bowel syndrome (IBS) development programs at the Digestive Disease Week (DDW) 2008 conference, to be held May 17-22 in San Diego, CA at the San Diego Convention Center. Phase 2a results for DDP225 in irritable bowel syndrome with diarrhea (IBS-d) will be featured in a podium presentation, and Phase 2a results for DDP733 in irritable bowel syndrome with constipation (IBS-c) will be presented in a poster session.

Dynogen’s IBS-d Study:

Abstract Title: A randomized, double-blind, placebo-controlled trial with a novel dual noradrenergic reuptake inhibitor (NARI) and 5-HT3 antagonist: Results of a Phase 2 8-week study in female patients with diarrhea predominant irritable bowel syndrome (d-IBS)

Session: Neurogastroenterology and Motility

Session Details: Monday, May 19, 5:15 PM PST in room 31BC

Reference Number: 432728

Presenter: Steven B. Landau, M.D., Healthcare Ventures, Cambridge MA; Dynogen Pharmaceuticals, Waltham MA

Dynogen’s IBS-c Study:

Abstract Title: A novel, oral 5-HT3 partial agonist, DDP733, improves overall response in patients with irritable bowel syndrome and constipation (IBS-c): A randomized, double blind, placebo-controlled, parallel-group, dose-ranging study

Session: Pharmacotherapeutics of Functional GI and Motility Disorders Poster Session

Session Details: Tuesday, May 20, 8:00 AM PST in the Sails Pavilion

Reference Number: 434958

Presenter: William G. Paterson, M.D., Queens University, Kingston, ON, Canada

In December 2007, Dynogen reported positive results from a randomized, double-blind, placebo-controlled Phase 2a clinical trial of DDP225 for IBS-d. DDP225 demonstrated a statistically significant difference in the clinical endpoint of adequate relief of IBS pain or discomfort compared to placebo, and the drug was well-tolerated. Further details will be presented in the podium presentation at DDW. Dynogen plans to initiate a Phase 2b trial of DDP225 in patients with IBS-d by the end of 2008.

In February 2007, Dynogen reported positive results from a randomized, double-blind, placebo-controlled Phase 2a study of DDP733 as a treatment for IBS-c. DDP733 demonstrated a statistically significant difference from placebo in the clinical endpoint of overall relief of IBS. Further details will be presented in the poster at DDW. Dynogen initiated a Phase 2b study of DDP733 in female patients with IBS-c in November 2007 and expects trial results by the end of 2008.

About DDP225

DDP225 is an oral low-potency inhibitor of the 5-HT3 receptor and of noradrenaline reuptake. The unique combination of noradrenaline reuptake inhibition and 5-HT3 antagonism in one orally delivered compound represents a novel approach to treating IBS-d, which Dynogen expects will enable efficacy to be achieved at very low and well-tolerated doses. In a recently completed randomized, double-blind, placebo-controlled Phase 2a clinical trial, DDP225 demonstrated a statistically significant difference in the endpoint of adequate relief of IBS pain or discomfort compared to placebo. The drug was safe and well-tolerated in this study. Dynogen expects to initiate a Phase 2b trial of DDP225 in patients with IBS-d in 2008.

About DDP733

DDP733 is an oral, minimally absorbed, partial agonist of the 5-HT3 receptor. A recently completed randomized, double-blind, placebo-controlled Phase 2a study of the candidate as a treatment for IBS-c demonstrated a statistically significant overall clinical response in the endpoint of relief of IBS. Additionally, in June 2007 Dynogen announced results from a Phase 1b translational medicine gastroesophageal reflux study of DDP733. In the 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 day of work. Zelnorm® (tegaserod, Novartis) was the only approved drug for IBS-c and was suspended from marketing by the FDA in March 2007, and is only available for use in emergency situations. Lotronex® (alosetron, Prometheus) is the only drug approved by the FDA for the treatment of IBS-d, but its use is restricted to women with severe disease who have not responded adequately to other therapies and is subject to a comprehensive and restrictive prescribing program.

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

Contact:

Dynogen Pharmaceuticals, Inc. Heather Savelle, 781-839-5149 hsavelle@dynogen.com or Media: MacDougall Biomedical Communications Christopher Erdman, 781-235-3060, ext. 14 cerdman@macbiocom.com

Source: Dynogen Pharmaceuticals, Inc.


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