Addex Starts Phase IIb ADX10059, Proton Pump Inhibitor Combination Study in GERD Patients
Addex Pharmaceuticals started a Phase IIb trial of ADX10059 as an add-on therapy to proton pump inhibitors (PPIs) for the treatment of gastroesophageal reflux disease (GERD), the cause of heartburn and other symptoms. The standard dose of PPI does not control GERD adequately in about 40% of patients. ADX10059 is a first-in-class reflux inhibitor that works by selectively inhibiting the metabotropic glutamate receptor 5 (mGluR5) through negative allosteric modulation. This approach may lead to a new class of drugs that addresses the causes of GERD rather than the symptoms.
Chief Medical Officer Charlotte Keywood said: "The aim of this trial is to give us information on the clinical effects of reflux inhibition by an mGluR5 inhibitor in patients who continue to have breakthrough symptoms whilst on PPIs. This study also may provide information on the most appropriate dose of ADX10059."
Study 205 is a double-blind, placebo-controlled, multi-center U.S. and European Phase IIb trial in about 280 GERD patients who are partial responders to proton pump inhibitors (PPIs). Patients in the trial will continue taking PPIs, the gold standard treatment for GERD, which work by reducing the acidity of the stomach contents. There will be a baseline symptom evaluation period followed by four weeks of administration of twice-daily ADX10059 (50mg, 100mg or 150mg). The primary endpoint is patient reported symptom control compared to baseline. Data are expected to be reported in late 2009.
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