Dynogen Reports Positive Results in Phase 1B GERD Study

WALTHAM, Mass.--(BUSINESS WIRE)--Jun 7, 2007 - Dynogen Pharmaceuticals, Inc. reported positive results of its randomized, double-blind, placebo-controlled Phase 1b trial of DDP733 for gastroesophageal reflux disease (GERD). The study was designed to demonstrate proof-of-concept for DDP733 as a treatment for nocturnal GERD (NGERD). The 0.5 mg dose of DDP733 achieved statistical significance over placebo on the primary endpoint of reduction in the number of reflux events and was safe and well tolerated. Dynogen is planning to initiate a Phase 2 study of DDP733 in GERD patients in 2008.

DDP733 is an oral, partial agonist of the serotonin type 3 receptor (5-HT(3)), which Dynogen is developing for gastrointestinal conditions such as GERD and irritable bowel syndrome with constipation (IBS-c). In this translational medicine study, healthy volunteers were given a high fat meal to induce gastroesophageal reflux. Reflux events were measured by intraesophageal impedance (the electrical resistance that provides insight into the height and duration of a reflux episode).

"With this second set of positive proof-of-concept data for DDP733, following closely on the heels of our positive Phase 2 data for DDP733 in irritable bowel syndrome with constipation, we've unlocked the potential of this compound as a treatment for two distinct and underserved GI disorders," said Lee R. Brettman, M.D., Chief Executive Officer at Dynogen. "We estimate the peak sales for these indications to be in excess of a billion dollars each, reflecting the significant unmet medical need represented by these disorders. Dynogen has the opportunity to make a real difference in the quality of life of many patients suffering from these disorders."

"We designed this study with the dual goals of obtaining an indication of efficacy and establishing appropriate doses for our later-stage clinical study, and I am pleased to say we accomplished both," said Dr. Suhail Nurbhai, MRCP, Vice President of Clinical Development at Dynogen. "DDP733, which targets the GI motility abnormalities central to GERD, has demonstrated a statistically significant reduction in the number of reflux events at a dose of 0.5 mg in this trial. We are now planning a larger Phase 2 study in GERD patients, where we will further build on these very promising results."

In February of this year, Dynogen announced positive results from its Phase 2 study of DDP733 in IBS-c, with a statistically significant improvement over placebo in the Subject Global Assessment of IBS. The Company plans to initiate a Phase 2b study in IBS-c this year.

About DDP733

DDP733 is an oral, partial agonist of the serotonin type 3 receptor (5-HT(3)). Serotonin is a neurotransmitter that is known to be involved in the control of the gastrointestinal (GI) system. Preclinical studies of DDP733 established the compound's prokinetic properties (the ability to promote the motility of the GI tract). Dynogen's preclinical studies have also shown that DDP733 is minimally absorbed by the cells lining the gastrointestinal tract and, as a result, more of the product candidate remains available at the desired local site of action. A recently completed Phase 2 study of the candidate as a treatment for IBS-c demonstrated an overall clinical response rate of 54% in patients receiving a dose of 1.4 mg t.i.d. compared to a 15% clinical response rate for patients receiving placebo, and the drug was also well-tolerated. Previous clinical studies of the compound have demonstrated favorable safety and pharmacokinetic profiles. Dynogen has exclusive rights under issued U.S. and European patents related to the use of DDP733 as a treatment for GERD.

About Nocturnal Gastroesophageal Reflux Disease (NGERD)

Gastroesophageal reflux disease (GERD) is a chronic condition that afflicts approximately 20 percent of adults in the United States. Persistent heartburn is the most common symptom of GERD, but patients may also experience acid regurgitation into the esophagus, dyspepsia (stomach pain) and dysphagia (difficulty swallowing). GERD affects all age groups, although the incidence increases markedly after the age of 40. If left untreated, complications of GERD can include esophageal erosions or ulcers and abnormal narrowing of the esophagus. Years of chronic heartburn, left untreated, can lead to esophageal cancer, currently the fastest growing cancer in the United States. NGERD is the occurrence of GERD at night, typically while lying down to sleep. Symptoms associated with stomach reflux are exacerbated by the lack of assistance from gravity while lying recumbent. NGERD is commonly associated with a higher risk and a higher degree of esophagitis; acid remains in the esophagus for prolonged periods because there is less swallowing and less saliva produced to neutralize the acid. It is estimated that approximately one-third of patients suffering from NGERD experience symptoms that are uncontrolled by current therapies.

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. Dynogen currently has multiple double-blind, placebo-controlled Phase 2 studies underway. www.dynogen.com

Contact

Dynogen Pharmaceuticals, Inc.
Mark Boshar, 781-839-5114
mboshar@dynogen.com
or
Media:
MacDougall Biomedical Communications
Kari Watson, 508-647-0209, ext. 11
kwatson@macbiocom.com

Posted: June 2007

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