ELGAN Pharma Awarded $2.5 Million EU Grant to Support Phase III Registrational Study of ELGN-GI for the Treatment of Intestinal Malabsorption in Preterm Infants

NAZARETH, Israel, July 19, 2023 /PRNewswire/ -- Elgan Pharma, a late-stage clinical biopharmaceutical company focusing on innovative treatments for critical conditions in neonates, announced today that it has been awarded by the European Innovation Council (EIC) a grant of €2.36 million ($2.5 million) in a highly competitive selection process. The grant will support the Phase III registrational study of ELGN-GI, an innovative oral formulation for the treatment of intestinal malabsorption, that causes feeding intolerance in preterm infants.  

"We are proud and excited to be awarded the EIC grant, that serves as a vote of confidence in our product and is a recognition of the importance of bringing to market medications for the treatment of intestinal malabsorption in premature infants," said Miki Olshansky, CEO of Elgan Pharma. "Feeding intolerance is a common symptom of intestinal malabsorption of prematurity among preterm infants, which is associated with increased risk of life-threatening complications. Across several clinical trials, ELGN-GI has demonstrated promising efficacy data in promoting maturation of the GI tract in preterm infants, resulting in significant reduction in life-threatening prematurity associated complications. Given the clinical data to date, we are confident that ELGN-GI holds the potential to improve the care of premature infants, paving the way for better outcomes and improved wellbeing of neonates worldwide. The company is launching a confirmatory Phase III trial as well as a Phase II trial in special neonatal populations."

The EIC is a flagship European program to identify, develop, and scale up innovative technologies. The funding is designed to support promising deep tech startups across different scientific, technological, sectoral and application fields.  

About ELGN-GI

ELGN-GI is a proprietary formulation of recombinant human insulin tailored for neonatal use, delivered orally and compatible with infants' nutrition. ELGN-GI improves gastrointestinal function and accelerates its development, thereby allowing a faster transition to full enteral nutrition, reducing the need for intravenous feeding and life-threatening complications.

About Gastrointestinal Complications in Preterm Infants

Preterm birth is a leading cause for infant mortality and morbidity, resulting in lengthy hospitalizations and various complications. A major hurdle impeding healthy growth of preterm infants in the initial stages of treatment is immaturity of the gut leading to malabsorption of nutrients from their enteral nutrition. It can also trigger life-threatening complications such as gut atrophy and necrotizing enterocolitis (NEC). To date, there is no approved treatment for intestinal malabsorption of prematurity, which remains an unmet medical need. Current management is by intravenous nutrition (parenteral nutrition- PN), that bypasses the gastrointestinal tract by delivering nutrients directly into the bloodstream. However, prolonged PN is associated with increased risks of infections and sepsis, liver damage, gut atrophy and poor developmental outcomes.

About Elgan Pharma

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 preterm infants' intestinal malabsorption and ELGN-EYE for prevention of preterm infants' retinopathy of prematurity, the number one cause of childhood blindness worldwide.

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SOURCE Elgan Pharma