Roscrea, Ireland-based biopharmaceutical company Renexxion and German pharmaceutical partner Dr. Falk Pharma are advancing naronapride into pivotal late-stage development for gastroparesis following positive results from the global Phase 2b MOVE-IT study, with Renexxion planning to file a new drug application with the US Food and Drug Administration using future Phase 3 results, according to First Word Pharma.

The decision to proceed to pivotal studies follows the 328-patient MOVE-IT trial, which demonstrated statistically significant improvement versus placebo across two dose groups in adults with moderate-to-severe idiopathic or diabetic gastroparesis symptoms.

Dr Kai Pinkernell, Managing Director of Science and Innovation at Dr. Falk Pharma, said: "These data reinforce our commitment to the program, and we look forward to advancing naronapride through late-stage development, working with Renexxion's team and bringing this important therapy to patients in need."

Dr Peter Milner, Chairman and chief executive of Renexxion, said: "Moving into pivotal studies is a significant milestone for naronapride and for the gastroenterology community. We look forward to continued collaboration towards approval."

The development programme is structured as a regulatory-harmonised global strategy, targeting approval in both the United States and Europe. Dr. Falk Pharma, which specialises in digestive and metabolic medicine, will lead the European development pathway while Renexxion pursues the US regulatory filing.

Gastroparesis is a chronic gastric motility disorder characterised by delayed stomach emptying, affecting a significant proportion of diabetic patients and those with idiopathic presentations. Current approved treatment options remain limited, representing a substantial unmet medical need within gastroenterology.

Read the full story for further detail on the naronapride Phase 3 programme and regulatory strategy.