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Dynogen Pharmaceuticals, Inc. Presents Results of Its Positive Phase 2 IBS-d Study with DDP225



5/20/2008 6:08:12 AM

WALTHAM, Mass.--(BUSINESS WIRE)--Dynogen Pharmaceuticals, Inc. announced today the presentation of positive results from its Phase 2a trial of DDP225 in patients with irritable bowel syndrome with diarrhea (IBS-d) at the Digestive Disease Week 2008 (DDW) scientific meeting. The randomized, double-blind, placebo controlled trial established clinical proof-of-concept with statistically significant results for the endpoint of relief of abdominal pain or discomfort associated with IBS-d. Dynogen previously reported top-line results from this Phase 2a trial in December 2007. The DDW abstract was co-authored by Dynogen and a team of investigators from leading clinical centers in Canada. The DDP225 results were presented yesterday in a Distinguished Abstract Plenary session on Neurogastroenterology and Motility by Steven B. Landau, M.D., a member of Dynogen’s Scientific Advisory Board.

In the trial, 87 females with IBS-d were randomized to one of four treatment groups (placebo, 1 mg, 3 mg or 5 mg of DDP225) and study medication was administered once daily for eight weeks. The primary clinical outcome measure was the response rate based on weekly patient reported assessment of adequate relief of IBS pain or discomfort. In the protocol specified analysis of adequate relief of IBS pain or discomfort for at least two of the last four weeks of study, the 1 mg dose of DDP225 demonstrated a statistically significant benefit over placebo (71% vs 25%; p=0.009). In an additional exploratory analysis of the proportion of patients with adequate relief for at least three of the last four weeks of study, the 1 mg dose again demonstrated a statistically significant benefit over placebo (53% vs 19%; p=0.041). All active dose groups demonstrated moderate sustained reductions in both stool frequency and consistency. A pharmacodymanic assessment of gastrointestinal transit was included in the study, but did not yield interpretable results. DDP225 was safe and well-tolerated in this study.

“There is currently only one FDA approved therapy available for women with IBS-d and its use is limited due to the potential for severe side effects. The results of this study support the hypothesis that applying IBS-relevant dual mechanisms at very low doses could maximize effectiveness and be well-tolerated, particularly on the relief of abdominal pain or discomfort which is a prominent feature of IBS for many patients. This profile underscores the potential for DDP225 to fill the significant unmet need for IBS-d patients and warrants further development of the drug candidate,” said Dr. Landau.

“I was particularly pleased with the high response rate and the adverse event profile we saw in this study,” commented Dr. Suhail Nurbhai, MRCP, Vice President of Clinical Development at Dynogen. “At the lowest dose, DDP225 achieved greater than 40% separation from placebo on responder rate, and had no serious or severe adverse events, or adverse events resulting in discontinuation. These data strongly support our belief that DDP225 has the potential to become a best-in-class treatment option for the millions of patients who suffer from IBS-d. We look forward to building upon these results and are moving toward initiation of a confirmatory Phase 2b study.”

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. Dynogen expects to initiate a Phase 2b trial of DDP225 in patients with IBS-d in 2008.

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 underserved 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 Source: Dynogen Pharmaceuticals, Inc.


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