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Scottish clinical research facility achieves global first in study of exciting new therapy for preterm infants
The Reproductive Health and Childbirth Team at Glasgow Clinical Research Facility (GCRF) has achieved a global first by enrolling the first twins into a vital new study aimed at treating a condition in preterm infants
Enrolled at Glasgow’s Royal Hospital for Children, the twins will be part of the FIT-PIV trial which will assess the efficacy and safety of ELGN-2112 for treating intestinal malabsorption in premature babies — a condition associated with life threatening complications.
The GCRF team is part of the phase 3 study which is expected to eventually enrol 420 infants at approximately 50 sites across the UK, US, Europe, and Israel.
The Glasgow trial is being led by Principal Investigators Judith Simpson and Helen McDevitt with Siobhan Moore acting as Research Midwife.
Judith said: “We are delighted that Glasgow is involved in this potentially very important trial and would like to emphasise that this is only possible due to the outstanding support we receive from the Clinical Research Facility team.
“Hopefully many vulnerable babies will benefit from this work in the future.”
Earlier this month, Israel-based Elgan Pharma and Italy-based biopharma Chiesi Farmaceutici said they were “thrilled” to be launching the trial and called the enrolment of its first infant patients “critical” to success.
Tailored for neonatal use, oral solution ELGN-2112 could improve gut function, in turn reducing the need for intravenous feeding, and decreasing the risk of complications.
Based on consistently positive results noted from other clinical trials to date, it is thought that ELGN-2112 can potentially become an important advance in the treatment of premature babies who are slow to tolerate milk feeding, thus prolonging their time on parenteral nutrition.
Premature babies have an immature gut at the time of birth, so those who fail to tolerate milk feeding remain dependent on nutrition delivered intravenously for some time. A situation that puts them at risk of complications such as sepsis and liver dysfunction.
Insulin-containing breast milk is known to partly protect against these complications and enhances normal gut development bur this becomes significantly less effective for premature babies after a few days.
Researchers believe that ELGN-2112 could counter this, allowing for accurate, low doses of insulin administration for preterm babies. It is compatible with all milks including mother’s own milk, donor breast milk, and infant formulas and contributes to gut rehabilitation with no systemic exposure to insulin.
Helen added: “Previous trials of ELGN-2112 have shown promising results with babies reaching their nutrition goals earlier and with fewer complications. We hope to further that vital research here in Scotland and help improve the health outcomes of preterm infants with intestinal malabsorption and intolerance of milk feeding.”
Clinical Research Manager at GCRF, Lynn Prentice said: “Thanks go to Research Nurse/Midwife Manager Therese McSorley and the wider team for these outstanding enrolment achievements and their ongoing hard work on the study.”
The GCRF employs a team of multidisciplinary staff, supporting a portfolio of over 400 clinical research studies, ranging from complex early phase or novel technique experimental medicine and medical device studies to large population-based public health initiatives.
Publication date: 25th June 2025
