Dr Falk Pharma, Renexxion Report Positive Phase 2b Naronapride Results

KUALA LUMPUR, May 5 (Bernama) -- Dr Falk Pharma GmbH (Dr Falk Pharma) and Renexxion Ireland Limited (Renexxion) announced a Phase 2b trial of naronapride met its primary endpoint in adults with gastroparesis, showing statistically significant improvements in symptom scores versus placebo.

Dr Falk Pharma Managing Director Science & Innovation, Dr Kai Pinkernell said the results showed a clinically meaningful impact on gastroparesis symptoms and supported further regulatory engagement and progression to late-stage development.

Meanwhile, Renexxion Chairman and Chief Executive Officer, Dr Peter Milner said the results represented a significant milestone for the programme, supporting naronapride’s potential as a best-in-class therapy for gastroparesis with a favourable safety profile.

The global, randomised, double-blind, placebo-controlled MOVE-IT study (NCT05621811) enrolled 328 adults with idiopathic or diabetic gastroparesis and assessed naronapride at doses of 10 milligramme (mg), 20 mg and 40 mg, administered three times daily over 12 weeks.

The trial met its primary endpoint, with the 20 mg and 40 mg dose groups showing statistically significant improvements versus placebo in the ANMS GCSI-DD Core Symptom Score, a patient-reported measure of gastroparesis symptoms, including nausea, vomiting and postprandial fullness.

Secondary and exploratory endpoints also showed consistent improvements, including reductions in composite symptom scores, with responder analyses indicating around 15 to 20 per cent more patients achieved clinically meaningful improvement in the 20 mg and 40 mg groups versus placebo.

According to the research-based pharmaceutical company in a statement, improvements in gastric emptying were also observed across all active doses.

Safety and tolerability profiles were reported as favourable, with no new safety signals identified across cardiac, neuropsychiatric or prolactin-related parameters. The companies said naronapride has been studied in more than 1,200 subjects to date, with minimal systemic absorption.

-- BERNAMA