Elgan Pharma Ltd. and Chiesi Farmaceutici S.p.A have announced the dosing of the first participating infants in FIT-PIV, a Phase 3 clinical study evaluating ELGN-2112 for the treatment of intestinal malabsorption in preterm infants. The condition represents a significant unmet medical need associated with life-threatening complications in this vulnerable population.
"We are thrilled to launch the FIT-PIV trial, with ELGN-2112, which we hope will improve outcomes for premature infants," said Miki Olshansky, Founder and CEO of Elgan Pharma. "Elgan Pharma is dedicated to developing therapies for preterm infants, targeting their unique unmet medical needs."
Phase 3 Trial Design and Scope
The FIT-PIV study is designed as a pivotal, multi-center, double-blind, randomized, two-arm, parallel-group, placebo-controlled trial to assess the efficacy and safety of ELGN-2112 on intestinal malabsorption in preterm infants. The study will enroll 420 infants born between 26-32 weeks gestation and weighing at least 500 grams.
The trial is expected to open at approximately 50 sites across the United Kingdom, Europe, Israel and the United States. The primary endpoint focuses on the number of days to achieve full enteral feeding (FEF), a critical milestone associated with reduced risk of complications in preterm infants.
Diego Ardigò, Executive Vice President of Global Research & Development at Chiesi Group, emphasized the significance of the enrollment milestone: "The enrollment of the first infant patients in this study is critical to our innovation in neonatology. Addressing intestinal malabsorption in preterm infants demonstrates Chiesi's ever-evolving approach to rare and emerging medical needs."
ELGN-2112 Mechanism and Previous Results
ELGN-2112 represents a proprietary formulation of recombinant human insulin specifically tailored for neonatal use. The drug is delivered enterally and designed to be compatible with all forms of infant nutrition, including mother's own milk, donor breast milk, and infant formulas. The formulation contributes to gut rehabilitation with no systemic exposure to insulin.
The therapeutic approach is based on insulin's natural physiological role in gastrointestinal development. Insulin is naturally present in amniotic fluid and breast milk during the first days of life, with evidence showing important effects on intestinal growth, cell maturation, and enzyme expression that improve the intestine's ability to absorb nutrition.
Previous clinical trials have demonstrated promising results for ELGN-2112. Infants treated with the investigational therapy in earlier studies, including a first Phase 3 trial, reached their nutrition goals earlier, had shorter time on parenteral nutrition, and experienced fewer complications compared to controls.
Addressing Critical Unmet Need
Intestinal malabsorption in preterm infants is characterized by an underdeveloped gastrointestinal tract that leads to inability to adequately absorb and tolerate enteral nutrition necessary for proper growth, neurological development, and gastrointestinal tract maturation. These infants become dependent on parenteral nutrition for their fluid and nutritional needs.
The combination of poorly functioning gastrointestinal tract and dependency on parenteral nutrition places this vulnerable population at risk for life-threatening complications, including necrotizing enterocolitis, while compromising long-term health and neurological developmental outcomes. Gastrointestinal complications also contribute to longer hospitalizations and increased healthcare system burden.
Clinical Development Strategy
The FIT-PIV study represents part of a comprehensive clinical development plan that includes additional studies for ELGN-2112. The novel formulation results in a highly soluble insulin powder for reconstitution, allowing for accurate, low doses appropriate for preterm babies.
ELGN-2112 is expected to improve gastrointestinal function, increase absorptive surface area, and enhance adaptation, thereby reducing the need for intravenous feeding and decreasing the risk of associated complications. Based on consistent positive results across several clinical trials to date, ELGN-2112 has the potential to become the first innovative therapeutic treatment for intestinal malabsorption in preterm neonates.
The collaboration between Elgan Pharma, a late-stage neonatology-focused biotechnology company, and Chiesi Group, an international biopharmaceutical company with decades of experience in neonatology, aims to address the unique medical needs of preterm infants and improve outcomes for this vulnerable population.
