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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
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TAG: Dynogen Reports Positive Results Phase GERD Study
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