Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, in collaboration with its partner Dr. Falk Pharma GmbH (“Dr. Falk Pharma”), announce dosing of the first patient in the United States (U.S.) in the ongoing global Phase 2b MOVE-IT study (ClinicalTrials.gov ID: NCT05621811) evaluating the safety and efficacy of naronapride for the treatment of gastroparesis. The MOVE-IT study started dosing patients in Europe in February 2023 and has now expanded to include U.S. patients after recent IND clearance from the FDA for investigating naronapride in gastroparesis patients. 

“As a part of our goal to harmonize clinical development and regulatory pathways in the U.S. and EU, we are delighted to announce the dosing of the first U.S. patient in our collaborative Phase 2b study with Dr. Falk Pharma, marking a key milestone in the development of naronapride for gastroparesis. This latest achievement is a testament to the strength of our joint-clinical development team, and our unwavering commitment to provide a safe and effective treatment for gastroparesis.” said Dr. Peter Milner M.D., FACC, Chairman, and CEO of Renexxion. “The rapid integration of multiple research sites across the U.S. signifies the widespread recognition of the potential benefits that naronapride may offer to patients with gastroparesis.” 

Dr. Kai Pinkernell, M.D., Managing Director, Science & Innovation at Dr. Falk Pharma, added, "As the partner in Europe and Australasia, we are pleased to announce that Renexxion has facilitated the expansion of our ongoing Phase 2b MOVE-IT study to clinical sites in the U.S. The extension of this study is a testament to our strong partnership and will expedite the clinical development of naronapride for gastroparesis in our respective territories, as well as for other indications related to impaired GI motility." 

Naronapride is a potential best-in-class oral, locally acting pan-GI prokinetic that works by modulating two validated targets on the luminal surface of the intestinal wall, 5-HT₄ receptor agonism and D₂ receptor antagonism, with a well-differentiated pharmaceutical, pharmacokinetics, safety, and efficacy profile from other 5-HT₄ agonists.  

Gastroparesis is characterized by delayed gastric emptying in the absence of mechanical obstruction and is caused primarily by diabetic and idiopathic etiologies, with some recent increases in iatrogenic disease potentially associated with widespread use of anti-obesity medications such as glucagon-like peptide-1 (GLP-1) agonists. Gastroparesis is a prevalent condition globally, with approximately 1.7% of the population in the U.S. and 1% in Europe having gastroparesis-like symptoms.  Gastroparesis affects 9.3% of patients with diabetes, while 15-30% of patients taking GLP-1 agonists experience nausea and 5-10% experience vomiting, both of which are common symptoms of gastroparesis. 

There is a large, unaddressed demand for a safe and efficacious long-term therapy for gastroparesis. GI prokinetics play a crucial role in managing this condition. However, the most prescribed options have limited efficacy and cause off-target side effects, including permanent damage to the central nervous system and life-threatening cardiac arrhythmias. Naronapride is a potential best-in-class solution for this large and underserved patient population due to its clinically validated dual-action therapeutic approach and its favorable safety profile to date, which has been demonstrated across four Phase 2 trials and eight Phase 1 trials. Moreover, naronapride has already shown dose-dependent acceleration of gastric emptying in a GI transit study involving healthy human volunteers.  

“The rising prevalence of gastroparesis means increasingly more patients are experiencing symptoms of abdominal discomfort, nausea and vomiting, without having access to a safe and efficacious long-term treatment,” said Jan Tack, MD, PhD, Professor and Head of Clinic in the Department of Gastroenterology at University Hospitals Leuven, Leuven, Belgium, and Principal Investigator for the MOVE-IT study. “A recently published meta-analysis demonstrated that pure 5-HT₄ agonists are associated with significant improvement in gastroparesis cardinal symptom index (GCSI) scores and faster gastric emptying time. This evidence supports the development of a novel 5-HT₄ receptor agonist with the added synergistic benefit of D₂ receptor antagonism, as a viable treatment for gastroparesis”, he added.