German research-based pharmaceutical company Dr. Falk Pharma and Irish clinical-stage biopharmaceutical firm Renexxion Ireland have announced positive results from the MOVE-IT Phase 2b trial evaluating naronapride in adults with gastroparesis, with the study meeting its primary endpoint across two dose groups, according to Globe Newswire.

The double-blind, randomised, placebo-controlled, multicenter trial enrolled 328 adults with moderate-to-severe idiopathic or diabetic gastroparesis symptoms and objective evidence of delayed gastric emptying. Eligible patients received either 10 mg, 20 mg, or 40 mg naronapride, or placebo, administered orally three times daily for 12 weeks.

MOVE-IT met its primary endpoint, demonstrating statistically significant improvement versus placebo in the ANMS Gastroparesis Cardinal Symptom Index Daily Diary Core Symptom Score in the 20 mg three-times-daily group (p=0.0046) and the 40 mg three-times-daily group (p=0.0156).

The ANMS GCSI-DD is a content-validated, patient-reported outcome instrument assessing five cardinal gastroparesis symptoms: nausea, vomiting, early satiety, postprandial fullness, and upper abdominal pain.

Gastroparesis is a chronic gastric motility disorder characterised by delayed stomach emptying in the absence of mechanical obstruction, affecting a significant proportion of patients with diabetes as well as those with idiopathic presentations. Current treatment options remain limited, representing a substantial unmet medical need.

The positive Phase 2b data position naronapride as a potential candidate for further late-stage clinical development, with Dr. Falk Pharma's specialisation in digestive and metabolic medicine providing a strong strategic foundation for advancing the programme toward Phase 3 evaluation.

Read the full article for comprehensive details on the MOVE-IT trial results and naronapride's clinical profile.