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news.Addex Pharmaceuticals, an allosteric modulation company, has started a Phase IIb trial of ADX10059 as an add-on therapy to proton pump inhibitors for the treatment of gastroesophageal reflux disease.
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Study 205 is a double-blind, placebo-controlled, multi-center US and European Phase IIb trial in about 280 gastroesophageal reflux disease (GERD) patients who are partial responders to proton pump inhibitors. Patients in the trial will continue taking proton pump inhibitors (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.
ADX10059 is a reflux inhibitor that works by selectively inhibiting the metabotropic glutamate receptor 5 through negative allosteric modulation. This approach may lead to a new class of drugs that addresses the causes of GERD rather than the symptoms, the company said.
Charlotte Keywood, chief medical officer of Addex, 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.”