Elgan Pharma and Chiesi Group Start Pivotal Phase 3 Study for Preterm Infants

Groundbreaking Phase 3 Study on ELGN-2112 Begins

In a significant advancement in neonatal healthcare, Elgan Pharma and Chiesi Group have officially announced the commencement of a Phase 3 clinical trial for their innovative drug candidate, ELGN-2112. This medication is specifically formulated to address a critical health issue—intestinal malabsorption—affecting preterm infants.

Overview of ELGN-2112

ELGN-2112 is a proprietary formulation of recombinant human insulin that is tailored for neonatal patients. Administered enterally, it is designed to enhance nutritional absorption in infants with underdeveloped gastrointestinal tracts. By potentially improving gastrointestinal function, ELGN-2112 aims to reduce the reliance on intravenous feeding, which is often associated with serious complications.

The Phase 3 study, titled FIT-PIV, is pivotal in evaluating both the efficacy and safety of this drug. With the participation of 420 infants—born between 26 to 32 weeks gestational age and weighing a minimum of 500 grams—the trial aims to enroll participants across approximately 50 sites located in the UK, Europe, Israel, and the United States.

Key Insights from the Trial

The primary endpoint of the FIT-PIV study is to determine the number of days required to achieve full enteral feeding (FEF), which is closely tied to lowering the risks of complications associated with premature births. Previous trials indicated that infants treated with ELGN-2112 reached their nutritional targets more quickly, experienced a shorter duration of parenteral nutrition, and encountered fewer complications.

Miki Olshansky, Founder and CEO of Elgan Pharma, expressed optimism about the trial, stating, “We are thrilled to launch the FIT-PIV trial, with ELGN-2112, which we hope will improve outcomes for premature infants.