GERD and PPI non-responsive GERD (PPI nrGERD)
Gastro-esophageal 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 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 western culture. The global age-standardised prevalence of gastroesophageal reflux disease was 8819 (7781–9863) cases per 100 000 population in 2017, and the disease was responsible for an estimated 0·7% (95% UI 0·4–1·1) of all years lived with disability globally in 2017 (Source: Sweis 2020). 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 prioritizing PPI non-responsive GERD (PPI nr-GERD) as a lead indication in the US. GERD affects ~65M people in the US up to 40% of patients (~8 to 10 million patients) are non-responsive to treatment with proton pump inhibitors (PPIs). The current treatments do no adequately address the dysmotility elements of GERD and there is a large unmet need for new treatments that improve outcomes and patients quality of life. Studies have demonstrated benefit with prokinetics but there are limited options for patients. We plan to conduct a Phase 2/3 study to demonstrate the benefit of naronapride in PPI non-responsive GERD, when given alongside double-dose PPIs for 8 weeks, to evaluate whether there is improvement in non-responsive GERD symptoms such as heartburn or regurgitation.
Renexxion Ireland is prioritizing PPI non-responsive GERD (PPI nr-GERD) as a lead indication in the US. GERD affects ~65M people in the US up to 40% of patients (~8 to 10 million patients) are non-responsive to treatment with proton pump inhibitors (PPIs). The current treatments do no adequately address the dysmotility elements of GERD and there is a large unmet need for new treatments that improve outcomes and patients quality of life. Studies have demonstrated benefit with prokinetics but there are limited options for patients. We plan to conduct a Phase 2/3 study to demonstrate the benefit of naronapride in PPI non-responsive GERD, when given alongside double-dose PPIs for 8 weeks, to evaluate whether there is improvement in non-responsive GERD symptoms such as heartburn or regurgitation.