Addex Achieves Statistically Significant Outcome in Phase IIa,Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease ( ay 1measurements were compared with Da...)

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

ay 1 measurements were compared with Day 2 for each patient, who therefore acted as his or her own control. The effect of two different doses, 50mg or 250mg of ADX10059, was tested in the study.

ADX10059 at the dose of 250 mg three times daily demonstrated statistically and clinically significant effects on both the physiological measures and clinical symptoms of GERD (see table below). The primary endpoint, the percentage of time that esophageal pH was greater than 4 during the 24-hour period, was statistically significantly increased during ADX10059 treatment (p = 0.014). In addition, the duration of acid reflux episodes, determined by esophageal pH measurement, was significantly reduced throughout the 24-hour period (p = 0.013). Importantly, night time reflux, which is often poorly controlled by conventional acid-suppressing therapies and results in sleep disturbance and increased risk of esophageal damage, was also significantly reduced by ADX10059 (p = 0.0021).,

The benefits on the physiological measures of reflux were also seen clinically, as patients reported fewer and shorter episodes of GERD symptoms on the active treatment day. 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 with 250mg ADX10059. The compound also appeared to show trends towards efficacy in some patients at the lower dose of 50mg three times daily, but the results for this group were more variable and were not statistically significant. Phase IIb trials in GERD are planned as a next step.

           Efficacy summary: ADX10059 250mg t.d.s compared to placebo

                                   t.d.s.



    Efficacy parameter        ADX10059 250mg    Placebo t.i.d. P value

                                   t.i.d

                                                    N = 11

                               
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