Study met primary and secondary endpoints, demonstrating unprecedented reduction in life-threatening prematurity associated complications
Results, published in JAMA Pediatrics, point to compelling efficacy of orally delivered ELGN-GI in promoting maturation of the GI tract in preterm babies
Company plans to initiate confirmatory Phase III registration trial in H2 2022 

Elgan Pharma, a late-stage clinical biopharmaceutical company focusing on innovative treatments for critical conditions in neonates, announced today outstanding results from a Phase III study evaluating the safety and efficacy of ELGN-GI, a proprietary enteral insulin formulation for the treatment of intestinal malabsorption, that causes feeding intolerance in preterm infants. The study results indicate an unprecedented improvement in gastrointestinal (GI) function and a reduction in related complications, including reduction in time until life threatening central line can be removed, reduction in hospital stay and a reduction in the number of life-threatening necrotizing enterocolitis (NEC) events. ELGN-GI was well tolerated, and no drug-related adverse effects were observed. The findings were recently published in JAMA Pediatrics.

"Feeding intolerance is a common condition among preterm infants due to immaturity of the gastrointestinal tract," commented Prof. Hans van Goudoever, former Division Chair of Pediatrics, Emma Children's Hospital Amsterdam UMC, Professor of Pediatrics and since 2022 Dean at the University of Amsterdam and Chief investigator of the ELGN-GI program. "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. I trust 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 Miki Olshansky, CEO of Elgan Pharma said. "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."

"In addition, we are on track to launching a Phase IIb clinical trial for ELGN-EYE, our second product candidate, for the treatment of pre-term infants' retinopathy of prematurity. In the past decades, there has been a lack of novel drugs specifically addressing infant health, and we are excited to be pioneers and propel this important underserved population forward with two promising additions," added Ms. Olshansky. Elgan Pharma is a clinical stage, neonatology-focused biotechnology company, dedicated to developing safe, tailored therapies to address medical complications and developmental challenges that are common in babies born prematurely. The company's two leading programs are ELGN-GI for the treatment of preterm infant intestinal malabsorption and ELGN-EYE for treatment of preterm infants' retinopathy of prematurity, the number one cause of childhood blindness worldwide. The Company was established in the NGT3 technological incubator.