KUALA LUMPUR, July 29 (Bernama) — The a2 Milk Company, a dairy nutrition company, has announced new clinical and preclinical research examining infant growth and safety, protein utilisation and gastrointestinal biomarkers, and digestive tolerance associated with A1- and A2-type beta-casein proteins.
Presented at NUTRITION 2026, the annual meeting of the American Society for Nutrition, the research included studies conducted by The a2 Milk Company as well as company-funded research by investigators from Purdue University and Nova Southeastern University.
The company presented results from a randomised, double-blind controlled trial evaluating infant formula made with milk free from A1-type beta-casein protein (A1PF) in healthy term infants.
The Growth Monitoring Study, which was required by the United States Food and Drug Administration (FDA) for new infant formulas, found that infants fed the A1PF formula experienced normal growth throughout the 16-week study period, meeting the FDA’s predefined non-inferiority criteria compared with a commercially available infant formula.
Additional analyses showed that infants receiving the A1PF formula recorded about six per cent greater average weight gain, around 6.6 per cent greater length gain, and higher weight-for-age and length-for-age z-scores at 16 weeks.
A separate preclinical study presented by The a2 Milk Company Senior Global Research Manager, Kirsty Armstrong, examined the protein component of A1PF infant formula using the Association of Official Analytical Collaboration (AOAC INTERNATIONAL) Protein Efficiency Ratio (PER) Official Method 960.48.
Key findings included higher adjusted PER, elevated antioxidant status, reduced gastrointestinal inflammatory markers, improved intestinal barrier function markers, and increased lactase gene and protein expression.
The company said the findings suggest that A1PF milk in infant formula may support improved protein quality and a more favourable gastrointestinal environment for nutrient utilisation, although further research is needed to determine the clinical significance of these findings.
Researchers from Purdue University also investigated the role of A1- and A2-type beta-casein in digestion and metabolism, while Nova Southeastern University examined how naturally occurring differences in milk proteins may influence inflammation in the gut and brain, contributing to ongoing research into the links between nutrition, inflammation, digestive health and cognitive function.
MOVE-IT met the primary endpoint with statistically significant improvement in gastroparesis symptoms in 20 mg and 40 mg TID doses vs placebo
Improvements observed across key symptoms, including nausea, early satiety, post-prandial fullness and upper abdominal pain
Favorable safety and tolerability profiles
Late-breaking oral presentation delivered at Digestive Disease Week (DDW) 2026 in Chicago, IL
FREIBURG, Germany and ROSCREA, Ireland, May 5 (Bernama-GLOBE NEWSWIRE) — Dr. Falk Pharma GmbH (“Dr. Falk Pharma”), a research-based pharmaceutical company specializing in digestive and metabolic medicine, and Renexxion Ireland Limited (“Renexxion”), a clinical-stage biopharmaceutical company, today announced positive results from MOVE-IT (NCT05621811), a global Phase 2b, randomized placebo-controlled trial evaluating the efficacy, safety, and tolerability of naronapride in adults with gastroparesis.
The double-blind, multicenter, 12-week study 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, 40 mg naronapride, or placebo, administered orally three times a day (TID) for 12 weeks.
MOVE-IT met the primary endpoint, demonstrating statistically significant improvement versus placebo in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Core Symptom Score in the 20 mg TID (p=0.0046) and 40 mg TID (p=0.0156) groups. The ANMS GCSI-DD is a content-validated, patient-reported outcome instrument that assesses the five cardinal gastroparesis symptoms: nausea, vomiting, early satiety, postprandial fullness and upper abdominal pain.
Table 1. Primary endpoint – Change from baseline to Week 12 in the average weekly ANMS GCSI-DD Core Symptom Score
Naronapride 10 mg TID
Naronapride 20 mg TID
Naronapride 40 mg TID
Placebo TID
Total Population
N=83
N=80
N=80
N=85
Baseline (BSL)
Week 12
Mean (SD)
Mean (SD)
2.450 (0.388)
1.155 (0.797)
2.429 (0.341)
0.883 (0.759)
2.462 (0.450)
0.907 (0.780)
2.402 (0.396)
1.280 (0.911)
Change to Week 12
LS Mean (SE) +/- 95% CI
-1.244 (0.100) [-1.440, -1.048]
-1.512 (0.102) [-1.712, -1.311]
-1.452 (0.100) [-1.649, -1.256]
-1.106 (0.095) [-1.293, -0.920]
Difference to Placebo
LS Mean (SE)
-0.138 (0.136)
-0.405 (0.137)
-0.346 (0.136)
Dunnett-Hsu Adjusted
97.5%-CI p-value†
[-∞, 0.183] 0.3112
[-∞, -0.081] 0.0046
[-∞, -0.024] 0.0156
CI = Confidence interval; LS Means = Least square means; N = Number of participants in analysis population; SD = Standard deviation; SE = Standard error. † One-sided
Naronapride also demonstrated statistically significant improvements versus placebo from baseline to Week 12 across key secondary and exploratory endpoints in the total population:
ANMS GCSI-DD Composite Score (core score excluding vomiting): Statistically significant improvements observed in 20 mg (p=0.0024) and 40 mg (p=0.0117) TID dose groups versus placebo.
Responder Analyses: Approximately 15-20% more participants achieved clinically meaningful improvement (defined as >1.0 decrease in ANMS GCSI-DD Composite Score) with naronapride 20 mg or 40 mg TID vs. placebo, with no added benefit of 40 mg over 20 mg.
Patient-Reported Quality of Life (QoL): Global improvements reflecting meaningful benefit beyond core symptom reduction and supporting consistency of treatment effect across validated symptom assessment instruments.
Improvement in gastric emptying breath test (GEBT): All active doses achieved greater gastric emptying versus placebo. Maximum improvement with 20 mg (mean -21.95 minutes) and 40 mg (mean –14.92 minutes) versus placebo (mean –10.96 minutes).
Consistent with previous studies, the safety and tolerability profiles were favorable, with no new safety signals identified versus placebo, including cardiac, neuropsychiatric, or prolactin-related signals. To date, naronapride has been studied in over 1200 subjects, with a safety profile reflecting its minimal systemic absorption.
Dr. Kai Pinkernell, M.D., Managing Director Science & Innovation at Dr. Falk Pharma, commented: “We are excited about the outcomes showing a significant and clinically meaningful impact on gastroparesis 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. We look forward to sharing these results with the scientific community, engaging with regulatory authorities, and moving decisively toward registration studies later this year and eventual commercialization.”
Dr. Peter Milner, M.D., FACC, Chairman and CEO of Renexxion, commented: “These Phase 2b results represent a significant milestone for the naronapride program, demonstrating statistically significant improvement in gastroparesis 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, a disease with significant unmet medical need and limited, safe, effective long-term treatment options. Together with our partner Dr. Falk Pharma, we are now focused on advancing naronapride into late-stage development with the goal of bringing an important new treatment option to physicians and patients.”
About Naronapride Naronapride is a potential best-in-class oral, locally acting pan-GI prokinetic designed to enhance coordinated motility across the digestive tract. Naronapride works through a differentiated dual mechanism of action- 5-HT4 receptor agonism and dopamine D2 receptor antagonism- modulating two validated targets on the luminal surface of the intestinal wall that regulate GI motility and nausea signaling. Naronapride’s dual pharmacology, minimal systemic bioavailability, and differentiated pharmaceutical and pharmacokinetic profile are designed to deliver targeted activity within the GI tract while limiting systemic exposure. To date, naronapride has demonstrated a favorable safety and tolerability profile across nine Phase 1 clinical trials and five Phase 2 clinical trials conducted in multiple indications including gastroesophageal reflux disease, erosive esophagitis and chronic idiopathic constipation.
About Gastroparesis Gastroparesis is a chronic gastrointestinal disorder characterized by delayed gastric emptying and debilitating symptoms including nausea, vomiting, early satiety, upper abdominal pain and postprandial fullness. Approximately 22 per 100,000 individuals across US and Europe are formally diagnosed with gastroparesis, 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.
About Renexxion Renexxion Ireland Limited, a wholly-owned Irish subsidiary of California-based Renexxion, Inc., is a privately held biopharmaceutical company committed to developing new therapies for patients with gastrointestinal disorders. Renexxion’s lead program is naronapride, a late-stage drug candidate being developed for multiple unmet indications in the upper and lower GI tract.
About Dr. Falk Pharma GmbH Dr. Falk Pharma GmbH has been developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis for over 60 years. As the international experts in digestive and metabolic medicine, the company brings together physicians, scientists, and patients to devise new and powerful approaches to patient care. Dr. Falk Pharma engages in pre-clinical and clinical stage research that aims to meaningfully improve therapeutic practice as well as patient health and well-being. A family-owned business with a global presence, Dr. Falk Pharma has ten affiliates in Europe and Australia and is continuously growing. The company has its headquarters and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, mainly at sites in Germany, France, Italy, and Switzerland. Falk employs approximately 1,550 individuals globally and 450 in Freiburg.
