Improved the health of premature infants and achieved the phase 3 clinical primary endpoint with innovative insulin preparation
Elgan Pharma today announced positive results from a Phase 3 clinical trial evaluating the safety and efficacy of ELGN-GI. Elgn-gi is an enteral insulin preparation for the treatment of intestinal malabsorption that leads to feeding intolerance in premature infants. The results showed improved gastrointestinal (GI) function and fewer life-threatening preterm birth related complications. In terms of safety, ELGN-GI was well tolerated and no drug-related adverse reactions were observed. The findings were published in the journal JAMA Pediatrics. The company plans to start a second Phase 3 clinical trial in the second half of this year.
Elgn-gi is a unique formulation of recombinant human insulin tailored for newborn babies and administered orally. It improves gastrointestinal function, increases absorption surface area and enhances adaptation, thereby reducing the need for intravenous feeding and life-threatening complications. This innovative formulation generates a highly soluble insulin powder that allows accurate low dose administration and is suitable for premature infants. It is compatible with breast milk and infant formula to aid intestinal recovery, eliminating the need for systemic insulin.
The phase 3 trial included 303 premature infants born between 26 and 32 weeks of gestation and weighing at least 500g. Subjects were randomized to receive low dose ELGN-GI (400 μIU/mL, n=110), high dose elGN-GI (2000 μIU/mL, n=95), or placebo (n=98). The primary endpoint was days to complete enteral feeding (FEF), defined as intake of at least 150 mL/kg/ day for 3 consecutive days, which marked a significant reduction in life-threatening risk.
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The trial reached its primary endpoint, compared with placebo (14.0 [8.0 — 28.0] days; N =85) compared with the low-dose group (10.0 [7.0-21.8] days; N = 94; P =0.03) and high-dose group (10 [6.0-15.0] days; N = 82; P =0.001) the time to complete enteral feeding was significantly shortened. And, the test also to other secondary end points, compared with the placebo group, the two active treatment group 6, 8 and 10 days after intervention to full enteral feeding significantly higher proportion of infants, intestinal for three consecutive days to intake of 120 mL/kg/day or time significantly shortened, high dose group received parenteral nutrition (parenteral nutrition) the number of days significantly lower than that of the placebo group.
In addition, overall, the percentage of subjects with major adverse events decreased from 18.6% in the placebo group to 12% in the low-dose group and 11.4% in the high-dose group. The reduction in serious complications and hospitalizations has contributed to a significant reduction in the burden on hospital staff and associated costs. None of the infants developed serum insulin antibodies, further establishing the safety of the treatment.
“Feeding intolerance is a common disease in premature infants due to immature intestinal mucosa.” “Feeding intolerance prolongs dependence on parenteral nutrition, which in turn increases the risk of short – and long-term life-threatening complications,” said Professor Hans van Goudoever, the study’s lead investigator. We are very pleased with the positive results of this trial, showing the multiple clinical benefits of ELGN-GI in improving the health of intestinal maturation and preterm infants. I believe ELGN-GI promises to improve the lives of premature babies and newborns with short bowel syndrome.”