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Addex Achieves Statistically Significant Outcome in Phase IIa,Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease

GENEVA, April 17, 2007 /PRNewswire/ -- Addex Pharmaceuticals announced today the successful completion of a Phase IIa proof of concept trial with its lead compound ADX10059 in patients with gastro-esophageal reflux disease (GERD), a highly prevalent condition with a significant unmet medical need. The study achieved its primary objective, the control of 24-hour esophageal pH, with statistical significance, and also showed statistically significant improvements in many of the secondary measures, including clinical symptoms of GERD. ADX10059 is also in clinical development in two other indications, migraine and anxiety.

Patients with GERD have a dysregulation of lower esophageal sphincter function, resulting in inappropriate relaxation of the sphincter muscle and causing reflux of stomach contents into the esophagus, particularly after meals and at night. Pre-clinical pharmacology studies have shown that metabotropic glutamate receptor 5 (mGluR5) inhibition reduces transient sphincter relaxation episodes, improves muscle tone of the lower esophageal sphincter, and prevents reflux of stomach contents into the esophagus. As ADX10059 is a selective mGluR5 negative allosteric modulator, it may have the possibility to reduce inappropriate esophageal sphincter relaxations and prevent reflux in man. Hence, a proof of concept study of the effect of this compound on gastro-esophageal reflux in patients with GERD was performed.

The single-blind, placebo-controlled, two-day study was performed in 24 male and female patients. The objectives were to evaluate the effect of ADX10059 on physiological measures of reflux, using continuous 24-hour pH recording in the lower esophagus, and on the occurrence of patient-recorded clinical symptoms of GERD. On Day 1 patients received placebo, while on Day 2 they received ADX10059 half an hour before each of three meals. The patients were unaware of the treatment sequence. D
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