RAMAT-GAN, Israel and MORRISTOWN, N.J., Nov. 3, 2016 /PRNewswire/ -- Nutrinia, Ltd. ("Nutrinia") is pleased to announce the enrollment of the first patient in its FIT-04 study. Nutrinia is developing NTRA-2112 as a treatment for preterm infants with intestinal malabsorption. NTRA-2112 is a novel oral formulation of insulin that acts locally in the gastrointestinal tract to accelerate intestinal maturation. Its unique formulation is suited for NICU use, as it can be stored at room temperature, is formulated for use with the equipment needed for enteral feeding, and can be easily administered with breast milk, formula or saline.
The FIT-04 Phase III trial is designed to support a full marketing application for this indication. The multi-center, double-blind, randomized placebo-controlled study will assess the efficacy and safety of NTRA-2112 in preterm infants born between 26 and 32 weeks gestation who are receiving parenteral nutrition. The primary endpoint is time to achieve full enteral feeding. This study is led by Professor Hans van Goudoever of The Academic Medical Center in Amsterdam as Chief Principal Investigator and will enroll up to 530 patients. For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02510560?term=nutrinia&rank=2Miki Olshansky, Nutrinia's Chief Executive Officer, said, "We believe that there is a compelling rationale supporting the potential of NTRA-2112 in accelerating intestinal maturation in this fragile patient group, and we are happy to begin enrollment in a well-controlled and sizeable trial in a small population with great unmet medical need." About Intestinal Malabsorption Intestinal malabsorption in preterm infants is a rare medical condition characterized by an underdeveloped gastrointestinal tract, leading to the inability to adequately absorb and tolerate the enteral nutrition necessary for proper overall growth, neurological development, and development of the gastrointestinal tract itself. These patients are dependent on parenteral nutrition for fluid and nutrition needs. The combination of a poorly functioning gastrointestinal tract and dependency on parenteral nutrition puts this vulnerable patient population at risk for life-threatening complications such as necrotizing enterocolitis, and compromises long-term health and neurological developmental outcomes. Accelerating the transition to enteral nutrition is a major goal for preterm infants in the NICU suffering from intestinal malabsorption.