Renexxion and Dr. Falk Pharma Expand Phase 2b MOVE-IT Study of Naronapride in Gastroparesis, Dose First U.S. Patient

Renexxion Ireland Limited, a private biopharmaceutical company focused on developing innovative drugs for gastrointestinal disorders, in partnership with Dr. Falk Pharma GmbH, has initiated the dosing of the first patient in the United States as part of the global Phase 2b MOVE-IT study. This study is designed to assess the safety and efficacy of naronapride for treating gastroparesis. The trial, which began patient dosing in Europe in February 2023, has now extended to the U.S. following the recent Investigational New Drug (IND) clearance from the FDA.

Dr. Peter Milner, Chairman and CEO of Renexxion, expressed his excitement about this milestone, emphasizing the importance of harmonizing clinical development and regulatory pathways between the U.S. and Europe. He highlighted the rapid integration of research sites across the U.S. as indicative of the recognition of naronapride's potential benefits for patients with gastroparesis.

Dr. Kai Pinkernell, Managing Director of Science & Innovation at Dr. Falk Pharma, noted that the expansion of the study to the U.S. is a testament to the strong partnership between the two companies and will expedite the development of naronapride for gastroparesis and other gastrointestinal motility disorders in their respective regions.

Naronapride is an oral, locally acting pan-GI prokinetic that targets the 5-HT4 receptor and D2 receptor on the intestinal wall, distinguishing itself from other 5-HT4 agonists with its unique pharmacokinetic and safety profile. Gastroparesis is a condition characterized by delayed gastric emptying without mechanical obstruction, often caused by diabetic or idiopathic factors. Recent trends suggest that the use of anti-obesity medications like GLP-1 agonists may also be contributing to increased cases of gastroparesis.

Gastroparesis affects a significant portion of the population, with 1.7% of people in the U.S. and 1% in Europe exhibiting symptoms. Diabetic patients are particularly affected, with 9.3% experiencing gastroparesis symptoms. Additionally, 15-30% of patients on GLP-1 agonists report nausea, and 5-10% report vomiting, common symptoms of gastroparesis.

The demand for effective long-term therapy for gastroparesis remains high. Current prokinetics often have limited efficacy and adverse side effects, including risks to the central nervous system and cardiac health. Naronapride, with its dual-action mechanism and favorable safety profile demonstrated in multiple Phase 1 and Phase 2 trials, offers a promising alternative. It has shown dose-dependent acceleration of gastric emptying in healthy volunteers.

Jan Tack, Professor and Head of Clinic in the Department of Gastroenterology at University Hospitals Leuven and Principal Investigator for the MOVE-IT study, emphasized the growing prevalence of gastroparesis and the need for effective treatments. He pointed out that recent studies have shown that 5-HT4 agonists significantly improve gastroparesis symptoms and gastric emptying time. Naronapride, with its additional D2 receptor antagonism, offers a synergistic benefit and represents a viable treatment option for gastroparesis.

Renexxion Ireland is also planning to initiate a Phase 2b study of naronapride for PPI-non-responsive symptomatic GERD and is preparing for a Phase 3 study in chronic idiopathic constipation (CIC). The MOVE-IT trial is a double-blind, randomized, multicenter, placebo-controlled study evaluating the efficacy, safety, and tolerability of naronapride in gastroparesis patients. It includes approximately 320 patients receiving different doses of naronapride over 12 weeks.

Renexxion Ireland is committed to developing novel drugs for GI disorders, with a particular focus on naronapride. Dr. Falk Pharma, a longstanding expert in gastrointestinal and hepato-biliary disorders, collaborates in this effort, leveraging its extensive experience and global presence. Both companies aim to bring innovative and effective treatments to patients with unmet medical needs.