Press release

Infant Bacterial Therapeutics (IBT) publishes results from ”The Connection Study” in Pediatric Research

IBT is pleased to announce that results from its pivotal Phase III trial, with IBP-9414 in very low birth weight infants “The Connection Study” have now been published in Pediatric Research (a Nature Publication).

This publication from “The Connection Study” provides an in-depth report on clinical outcomes, concluding that IBP-9414 treatment was safe and reduced both mortality and surgically-confirmed NEC in vulnerable VLBW infants.

“This peer-reviewed article shows IBP-9414’s potential to save prematurely born infants' lives. More than a decade ago, IBT took on the challenge of helping these infants, and the results of this study validate our approach. I wish to thank everybody involved in the study -all medical staff, patients, their families, and IBT personnel,” says Staffan Strömberg, CEO at IBT

“All-cause mortality is among the most rigorous and clinically meaningful endpoints in studies of preterm infants. The mortality findings from this trial support the potential of IBP-9414 to improve outcomes in this vulnerable population.”
says, Principal Investigator Josef Neu, MD, Department of Pediatrics, University of Florida.

Pediatric Research is a Nature publication and is the official publication of the American Pediatric Society, the European Society for Paediatric Research, and the Society for Pediatric Research.

For access to the article: https://doi.org/10.1038/s41390-026-04826-7

About IBT
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm (IBTB) since September 10, 2018.

IBT is a pharmaceutical company whose mission is to develop and commercialize drugs for diseases affecting premature babies.
IBT's main focus is the drug candidate IBP-9414, a formulated bacterial strain naturally found in human breast milk. IBP-9414, is expected to be the first product in the new class of biologics called "Live Biotherapeutic Products" for premature infants. The development of IBP-9414 is currently in its final stages.

In the recent Phase III Connection study in premature infants that was completed in July 2024, the group treated with IBP-9414 demonstrated a significant 27% reduction in all-cause mortality compared with the placebo group, meaning that widespread use of IBP-9414 could save more than 1000 patients annually in the US alone. The therapy has received both Breakthrough Therapy Designation (March 2025) for gastrointestinal related mortality and Rare Paediatric Disease Designation, reflecting its potential to address a significant unmet medical need.

The portfolio also includes additional drug candidates, IBP-1016, IBP-1118 and IBP-1122. IBP-1016, for the treatment of gastroschisis, a life-threatening and rare disorder in which children are born with externalized gastrointestinal organs. IBP-1118 to prevent retinopathy of prematurity (ROP), one of the leading causes of blindness in premature babies, and IBP-1122 to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital infections.
Through the development of these drugs, IBT can address medical needs where no sufficient treatments are available.