NTRA PROMOTES GI DEVELOPMENT AND ENHANCES BOWEL ADAPTATION
Multiple clinical and preclinical studies have shown compelling evidence that NTRA improves GI function, increases absorptive surface area of the gut and enhances intestinal adaptation. The active substance in NTRA is insulin, as found in amniotic fluid and mothers’ milk in the first few days following birth (colostrum), making it a natural and safe medication for infants. NTRA provides premature babies with what nature intended.
Preterm infants and patients with intestinal failure commonly cannot tolerate the level of enteral nutrition sufficient to support normal growth and development. Therefore, they are placed on parenteral nutrition (PN) support for prolonged periods. Enhancing GI functionality and absorption and reducing PN dependency are extremely important for these patients. NTRA can be used to improve their GI development and reduce long- and short-term morbidities.
THE CHALLENGE: SAFE AND ACCURATE INSULIN ADMINISTRATION TO THE TINIEST INFANTS
Human insulin is a complex hormone. It is a protein composed of 51 amino acids and has a limited shelf life. It is also sensitive to environmental conditions such as temperature, humidity, and oxidative stress.
Additionally, drug formulation for use in the NICU (Neonatal Intensive Care Unit) for infant consumption has stringent requirements. Preemies are fed via the thinnest feeding tubes—as small as 2mm in width—and medications must be able to pass uniformly and continuously through these tubes. Beyond that, all additional ingredients in the formulation must be NICU-compliant and safe for administration to newborns—a high bar.
Nutrinia has worked relentlessly to develop products to meet these challenges and make a true difference to patients.
NTRA OVERCOMES THE CHALLENGE OF FORMULATING INSULIN FOR ORAL USE IN INFANTS
NTRA is composed of insulin and excipients considered extremely safe and approved for infant consumption. Manufactured as a powder that can be stored at room temperature, NTRA is mixed with infant formula or saline just prior to use.
NTRA increases enteral nutrition capacity, which improves growth and development and is linked to better long-term outcomes. Multiple non-clinical and clinical studies show that NTRA also reduces short-term parenteral nutrition dependency, leading to significant reduction in morbidity and risk to the infant. Key features:
NTRA’S TECHNOLOGY FACILITATES INSULIN ABSORPTION IN 3 MAIN STEPS
Step 1: Oral Delivery
Following powder reconstitution, the oral formulation is ingested by the patient. The reconstituted powder flows freely through an extremely small, 2–3mm diameter (5 French) feeding catheter.
Step 2: NTRA binds to insulin receptors throughout the GI
NTRA reaches specific insulin receptors in the bowel (on the villi and the microvilli) and binds to them.
Step 3: Receptor-mediated effect stimulates intestinal villi
As insulin binds to the receptors on the villi and microvilli, it stimulates development and contributes to bowel rehabilitation.
CLINICAL AND NON-CLINICAL ACHIEVEMENTS SHOW SAFETY AND EFFICACY
Clinical and non-clinical studies in multiple species demonstrated safety in animal models and in patient populations.
No side effects
No therapy-related events
No systemic exposure detected
No anti-insulin antibodies
No abnormal blood test results
No toxicity findings