Renexxion Ireland Limited, a wholly owned Irish subsidiary of California-based Renexxion, Inc., is a privately held biopharmaceutical company committed to delivering new drugs to patients with GI disorders. We are focused on advancing the late-stage clinical development of our lead program, naronapride, a potential best-in-class drug candidate for indications in the upper and lower GI tract, which have limited treatment options. Currently, we are collaborating with a leading European GI Licensing partner, Dr. Falk Pharma, GmbH, to advance naronapride through the clinic and into commercialization in Greater Europe and certain other Australasian countries.
Naronapride is a late-stage, potential best-in-class drug candidate for indications in the upper and lower GI tract with high unmet medical needs. In scientific studies naronapride has demonstrated that it possesses a unique combination of both serotonin 5HT4 receptor agonistic and dopamine D2 receptor antagonistic properties, both clinically validated targets. Naronapride was designed to be minimally absorbable and locally active in the gut lumen to potentially enhance efficacy and safety. To date, five Phase 2 studies have been completed and shown positive data, including in the most recent global Phase 2b trial (MOVE-IT), which met the primary endpoint, demonstrating statistically significant improvement in gastroparesis symptoms versus placebo, along with favorable safety and tolerability profiles. We are currently planning a global Phase 2b trial in PPI non-responsive symptomatic GERD with our partner, Dr. Falk.
It is estimated that at least 16% of people worldwide are affected by GI-related disorders. Currently approved therapies do not completely address the high therapeutic need. Naronapride has the potential to address major GI indications, including gastroparesis, and PPI non-responsive symptomatic gastroesophageal reflux disease (GERD). (More...)