GERD and PPI non-responsive symptomatic GERD (PPI-nrsGERD)
Gastroesophageal reflux disease (GERD) is a digestive system disorder characterized by an incomplete closure of the barrier between the stomach and the esophagus, resulting in backward flow of the acidic stomach content as well as non-acidic fluids into the esophagus. This results in symptoms such as heartburn, an acidic taste in the mouth, and painful swallowing. Over time, damage to the lining of the esophagus and risk of esophageal cancer may occur. Approximately $17.0 billion is spent worldwide each year on GERD and heartburn medications. GERD is one of the most common gastrointestinal disorders, with a prevalence of approximately 20% of adults in the west. Even when the treatment is effective, relief is often incomplete or only temporary and the evidence points to gastric dysmotility as the problem in these subjects. This is one of the large unmet need populations that is targeted with naronapride.
Renexxion Ireland is pursuing PPI non-responsive symptomatic GERD (PPI-nrsGERD) as an indication in the US. GERD affects ~65M people in the US, and up to 40% of patients are non-responsive to treatment with proton pump inhibitors (PPIs). The current treatments do not adequately address the dysmotility elements of GERD and there is a large unmet need for new treatments that improve outcomes and patient quality of life. Studies have demonstrated benefit with prokinetics but there are limited options for patients. We plan to conduct a Phase 2b study to demonstrate the benefits of naronapride in PPI-nrsGERD, when given for 8 weeks, alongside PPIs. The study will evaluate whether there is improvement in heartburn and other symptoms.
Renexxion Ireland is pursuing PPI non-responsive symptomatic GERD (PPI-nrsGERD) as an indication in the US. GERD affects ~65M people in the US, and up to 40% of patients are non-responsive to treatment with proton pump inhibitors (PPIs). The current treatments do not adequately address the dysmotility elements of GERD and there is a large unmet need for new treatments that improve outcomes and patient quality of life. Studies have demonstrated benefit with prokinetics but there are limited options for patients. We plan to conduct a Phase 2b study to demonstrate the benefits of naronapride in PPI-nrsGERD, when given for 8 weeks, alongside PPIs. The study will evaluate whether there is improvement in heartburn and other symptoms.