Kuala lumpur: Dr Falk Pharma GmbH and Renexxion Ireland Limited: Dr Falk Pharma GmbH (Dr Falk Pharma) and Renexxion Ireland Limited (Renexxion) have announced promising results from their Phase 2b trial of naronapride, which successfully met its primary endpoint in adults suffering from gastroparesis. The trial demonstrated statistically significant improvements in symptom scores compared to a placebo, marking a significant step forward in treating this condition.
According to BERNAMA News Agency, Dr Kai Pinkernell, Managing Director of Science and Innovation at Dr Falk Pharma, emphasized the clinical relevance of these findings. He stated that the results not only showcase a meaningful impact on gastroparesis symptoms but also pave the way for further regulatory discussions and progression to late-stage development.
Renexxion Chairman and CEO, Dr Peter Milner, highlighted that the trial results are a pivotal milestone for the naronapride program. He noted that the findings bolster the potential of naronapride to emerge as a best-in-class therapy for gastroparesis, offering a favorable safety profile along the way.
The global MOVE-IT study (NCT05621811), which was randomized, double-blind, and placebo-controlled, involved 328 adults diagnosed with either idiopathic or diabetic gastroparesis. Participants were administered naronapride in doses of 10 mg, 20 mg, and 40 mg three times daily over a 12-week period. The trial achieved its primary endpoint, with the 20 mg and 40 mg dose groups showing statistically significant improvements in the ANMS GCSI-DD Core Symptom Score, a patient-reported measure of symptoms including nausea, vomiting, and postprandial fullness, compared to the placebo.
Secondary and exploratory endpoints revealed consistent improvements, with reductions in composite symptom scores. Responder analyses indicated that approximately 15 to 20 percent more patients in the 20 mg and 40 mg groups experienced clinically meaningful improvements compared to those receiving a placebo.
the pharmaceutical companies reported improvements in gastric emptying across all active doses. Safety and tolerability were favorable, with no new safety signals detected in cardiac, neuropsychiatric, or prolactin-related parameters. Naronapride has been studied in over 1,200 subjects thus far, exhibiting minimal systemic absorption.