The Phase III study showed that ELGN-GI not only improved gastrointestinal (GI) function, but it also reduced life-threatening complications.
On Wednesday, Israel-headquartered Elgan Pharma released the findings of its Phase III study on the safety and efficacy of an insulin formulation for the treatment of intestinal malabsorption in preterm infants, called ELGN-GI.
Premature birth significantly raises the risk of infant mortality. An estimated 15 million babies are born preterm each year, and they face a number of possible complications that together were responsible for approximately one million deaths of children under five years of age in 2015.
A late-stage clinical biopharmaceutical company, Elgan Pharma innovates new solutions in critical neonatal care. This time, the outfit has developed a treatment for feeding intolerance in preterm infants caused by intestinal malabsorption.
The Phase III study showed that ELGN-GI not only improved gastrointestinal (GI) function, but it also reduced life-threatening complications, as well as time taken to stabilize the infant. Usage also led to shorter hospital stays and a reduction in life-threatening necrotizing enterocolitis (NEC) events. Neonatal infants tolerated ELGN-GI well and did not suffer side effects.
“Feeding intolerance is a common condition among preterm infants due to immaturity of the gastrointestinal tract,” said Professor Hans van Goudoever, professor of pediatrics and dean at the University of Amsterdam and the program’s chief investigator. “Feeding intolerance prolongs dependence on parenteral nutrition which, in turn, is associated with increased risk of short- and long-term life-threatening complications. We are very excited to see the positive results of this trial, showing multiple clinical benefits for ELGN-GI in improving intestinal maturation and the wellbeing of preterm infants.”
He added his belief that ELGN-GI holds the potential to improve the lives of premature infants and neonates suffering from short bowel syndrome.
“One out of ten babies is born premature. The challenge that faces us is developing new therapies for unique unmet medical needs of this special population,” said Elgan CEO Miki Olshansky. “We are confident that ELGN-GI will be an important therapy for premature infants given its remarkable consistent clinical data across several trials to date. We look forward to initiating our second Phase III trial for ELGN-GI in the second half of 2022 towards registration.”
The Phase III trial, conducted across 46 sites in the U.S., Europe and Israel, was randomized double-blind and placebo-controlled. The aim of the study was to determine safety and efficiency in preterm infants within certain parameters. Researchers randomly administered either high-dose, low dose or placebos for a month.
The main benchmark for success was whether the infants reached full enteral feeding (FEF), which meant an intake of at least 150 ml/kg per day for three consecutive days. Other considerations were the percentage of infants reaching full enteral feeding within 6, 8 and 10 days of intervention; time to achieve an enteral intake of ≥120 mL/kg per day for three consecutive days, the number of days receiving parenteral nutrition and growth rate.
Both high and low doses proved effective by all these measures when compared against the placebo. When on ELGN-GI, infants reached FEF at much higher rates and life-threatening complications were reduced.
ELGN-GI, a human insulin formulation, acts by improving gastrointestinal function, increasing absorptive surface area and enhancing adaptation. It can be taken orally and administered alongside the mother’s own milk and formula.
Prof. van Goudoever went on to say that the program is preparing to start a Phase IIb clinical trial for the treatment of retinopathy associated with prematurity, ELGN-EYE. This is another condition currently in need of treatments formulated specifically for infants and in line with the company’s mission to reduce the many risks that the 10 percent of infants born prematurely face.
