(RTTNews) - Addex Pharmaceuticals (ADDXF.PK: News ) said it achieved statistically significant efficacy on the primary endpoint, increasing the number of symptom free days in the Phase IIb trial of ADX10059 as a monotherapy in patients with gastroesophageal reflux disease, or GERD.

ADX10059 is a first-in-class reflux inhibitor that works by reducing activation of the metabotropic glutamate receptor 5 through negative allosteric modulation.

According to the company, study ADX10059-204 was a double-blind, placebo-controlled, multi-center European Phase IIb trial in 103 GERD patients known to respond well to proton pump inhibitors. The primary clinical endpoint was the patient reported number of GERD symptom free days in week 2 of treatment compared to the last 7 days of baseline.
The company noted that ADX10059 significantly increased the mean number of GERD symptom free days in week 2 of treatment. At baseline the mean number of symptom free days was 0.46 in the ADX10059 group and 0.72 days in the placebo group. During treatment week 2 this increased to 2.5 days in the ADX10059 group and to 1.71 days in the placebo group.

In addition to the primary efficacy endpoints, ADX10059 showed statistical superiority over placebo for a variety of secondary variables including an increase in heartburn free days, a reduction in sleep disturbance, a reduction in the requirement for antacid medication, an improvement in a GERD symptom patient reported outcome questionnaire. Finally patients also expressed a significant preference for ADX10059 treatment compared to placebo.

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by RTT Staff Writer

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