Study into treatment for rare condition in premature infants launches globally

Ella Day | June 9, 2025 | News story | Research and Development |  Chiesi Farmaceutici, Elgan Pharma, Gastrointestinal tract, Paediatrics, clinical trial, intestinal malabsorption, premature infant health 

Elgan Pharma, specialising in neonatology, and Italy-based biopharma, Chiesi Farmaceutici, have announced the dosing of the first participating infants in FIT-PIV, a phase 3 clinical study of ELGN-2112, a prospective treatment for intestinal malabsorption in preterm infants.

The FIT-PIV study is expected to roll 420 infants, born 26-32 weeks and weighing at least 500g, at approximately 50 sites across the UK, US Europe and Israel. Previous trials, including a first phase 3, had promising results as babies treated with ELGN-2112 reached their nutrition goals earlier and their time on parenteral nutrition was shorter and had fewer complications.

Intestinal malabsorption in premature infants is a rare medical condition characterised by an underdeveloped gastrointestinal tract, leading to the inability to effectively absorb and tolerate the enteral nutrition necessary for overall growth. This leaves infants dependent on parenteral nutrition and vulnerable to life-threatening complications, such as necrotising enterocolitis, as well as compromising long-term health and neurological development outcomes.

ELGN-2112 is a proprietary formulation of recombinant human insulin designed for neonatal use. It aims to improve gastrointestinal function, increase absorptive surface area and enhance adaptation, reducing the need for intravenous feeding and the risk of life-threatening complications.

“We are thrilled to launch the FIT-PIV trial, with ELGN-2112,” said Miki Olshansky, founder and CEO of Elgan. “Together with our partners at Chiesi, we are committed to improving the outcomes and care of premature infants.”

Ella Day
9/6/25