ADX10059 in GERD

In data from Addex Phase IIa trial, released in April 2007, ADX10059 reduced the extent of esophageal acid exposure compared to placebo. The primary endpoint, the percentage of time that esophageal pH (a measure of acidity) was less than 4 during a 24-hour period, was statistically significantly improved during ADX10059 treatment compared to placebo administration. Importantly, night time reflux, which is often poorly controlled by conventional acid-suppressing therapies and causes sleep disturbance and increased risk of esophageal damage, was also significantly reduced by ADX10059 (see Fig. 2.1).

ADX10059 also reduced exposure of the esophagus to acid during the critical periods following meals, when GERD can be most troublesome and most resistant to marketed therapies (see Fig. 2.2).


The benefits on the physiological measures of reflux were also observed as a reduction in clinical symptoms. Patients reported fewer and shorter episodes of GERD symptoms on the active treatment day. Specifically, on the placebo treatment day, patients experienced an average of 7 symptomatic episodes, each lasting an average of 14 minutes. These were reduced to an average of 2 episodes, each lasting 5 minutes during treatment (see Fig. 2.3).

ADX10059 Phase IIa GERD data were presented at the 2007 United European Gastroenterology Week, a peer reviewed clinical research conference in October 2007.