Naronapride Shows Statistically Significant Improvement in Gastroparesis Symptoms in Phase 2b MOVE-IT Trial
核心洞察
Dr. Falk Pharma (搜索) and Renexxion (搜索) announced positive results from the Phase 2b MOVE-IT trial, with naronapride meeting its primary endpoint and demonstrating statistically significant improvement in gastroparesis (搜索) symptoms at 20 mg and 40 mg doses versus placebo.
The 12-week study enrolled 328 adults with moderate-to-severe idiopathic or diabetic gastroparesis (搜索), showing improvements across key symptoms including nausea (搜索), early satiety, postprandial fullness, and upper abdominal pain.
Naronapride demonstrated a favorable safety and tolerability profile with no new safety signals identified, positioning it as a potential treatment option for a condition with limited effective therapies.
Dr. Falk Pharma (搜索) and Renexxion (搜索) have announced positive results from the Phase 2b MOVE-IT trial evaluating naronapride in adults with gastroparesis (搜索), a chronic gastrointestinal disorder with limited treatment options. The global, randomized, placebo-controlled study met its primary endpoint, demonstrating statistically significant improvement in gastroparesis symptoms compared to placebo.
Trial Design and Patient Population
The double-blind, multicenter, 12-week study enrolled 328 adults with moderate-to-severe idiopathic or diabetic gastroparesis (搜索) symptoms and objective evidence of delayed gastric emptying. Eligible patients received either 10 mg, 20 mg, 40 mg naronapride, or placebo, administered orally three times daily for 12 weeks.
Primary Endpoint Results
MOVE-IT met its primary endpoint, showing statistically significant improvement versus placebo in the American Neurogastroenterology and Motility Society Gastroparesis (搜索) Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Core Symptom Score. The 20 mg three times daily group achieved statistical significance with p=0.0046, while the 40 mg three times daily group showed p=0.0156. The ANMS GCSI-DD assesses five cardinal gastroparesis symptoms: nausea (搜索), vomiting (搜索), early satiety, postprandial fullness, and upper abdominal pain.
The least square mean change from baseline to Week 12 showed improvements of -1.512 for the 20 mg group and -1.452 for the 40 mg group, compared to -1.106 for placebo. The difference to placebo was -0.405 for the 20 mg dose and -0.346 for the 40 mg dose.
Secondary and Exploratory Endpoints
Naronapride demonstrated statistically significant improvements across multiple secondary endpoints. The ANMS GCSI-DD Composite Score showed significant improvements in both the 20 mg (p=0.0024) and 40 mg (p=0.0117) dose groups versus placebo.
Responder analyses revealed that approximately 15-20% more participants achieved clinically meaningful improvement, defined as greater than 1.0 decrease in ANMS GCSI-DD Composite Score, with naronapride 20 mg or 40 mg compared to placebo. Notably, the 40 mg dose provided no added benefit over the 20 mg dose.
Patient-reported quality of life measures showed global improvements reflecting meaningful benefit beyond core symptom reduction. Gastric emptying breath test results demonstrated that all active doses achieved greater gastric emptying versus placebo, with maximum improvement observed in the 20 mg group (mean -21.95 minutes) and 40 mg group (mean -14.92 minutes) versus placebo (mean -10.96 minutes).
Safety Profile
The safety and tolerability profiles were favorable, consistent with previous studies. No new safety signals were identified versus placebo, including cardiac, neuropsychiatric, or prolactin-related signals. To date, naronapride has been studied in over 1,200 subjects, with a safety profile reflecting its minimal systemic absorption.
Clinical Significance and Development Plans
Dr. Kai Pinkernell, Managing Director Science & Innovation at Dr. Falk Pharma (搜索), stated: "We are excited about the outcomes showing a significant and clinically meaningful impact on gastroparesis (搜索) symptoms, all combined with a favorable safety profile. This is an important step towards providing physicians and patients with a treatment option where few effective choices exist."
Dr. Peter Milner, Chairman and CEO of Renexxion (搜索), commented: "These Phase 2b results represent a significant milestone for the naronapride program, demonstrating statistically significant improvement in gastroparesis (搜索) symptoms with a favorable safety and tolerability profile. We believe naronapride's locally acting, dual mechanism pharmacology and safety-by-design profile position it as a potential best-in-class therapy for gastroparesis."
The companies plan to engage with regulatory authorities and move toward registration studies later this year, with the goal of eventual commercialization.
About Naronapride and Gastroparesis
Naronapride is a potential best-in-class oral, locally acting pan-GI prokinetic designed to enhance coordinated motility across the digestive tract. It works through a dual mechanism of action involving 5-HT4 receptor (搜索) agonism and dopamine D2 receptor (搜索) antagonism, modulating validated targets on the luminal surface of the intestinal wall that regulate GI motility and nausea (搜索) signaling.
Gastroparesis (搜索) affects approximately 22 per 100,000 individuals across the US and Europe who are formally diagnosed, while up to 12 times more experience symptoms consistent with the disease. Despite the substantial disease burden, the availability of safe and effective long-term treatment options remains limited.