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Infant Bacterial Therapeutics AB
(publ)
Annual Report 2025
IBT’S PIPELINE
IBP-9414
IBP-9414 contains L. reuteri as its active ingredient, which is a human bacterial strain found
naturally in breast milk. L. reuteri is a bacterium known for its anti-inflammatory and anti-
pathogenic properties, as well as its beneficial effects on intestinal motility and the maturation
of the intestinal mucosa. All these factors contribute, among other things, to preventing NEC,
which is characterized by severe inflammation and pathogen activity, as well as inhibition of
intestinal motility and maturation. IBP-9414 has been formulated with the vulnerable target
population of preterm infants in mind.
IBT received orphan drug designation from the FDA for L. reuteri for the prevention of NEC in
premature infants in 2013 and from the European Commission in 2015. IBT received Rare
Pediatric Disease designation for IBP-9414 from the FDA in 2016.
In June 2016, IBT initiated a safety and tolerability study. By the end of 2017, the study results
demonstrated a similar safety and tolerability profile in both the active and placebo groups.
In November 2018, following discussions with the FDA, IBT decided to modify the protocol for
the Phase III study of IBP-9414, which was designed to prevent necrotizing enterocolitis (NEC)
in premature infants. In accordance with guidance from the FDA, IBT amended the protocol to
allow for additional treatment endpoints, such as a reduction in the time until the infant could
manage without intravenous nutrition. In the Phase III study, “sustained feeding tolerance”
(SFT) was measured to assess the shortened time.
The pivotal Phase III study, “The Connection Study,” was initiated in 2019, and the first patient
was enrolled in July 2019. In December 2021, a blinded analysis was presented showing that
a reduction in the time to SFT also correlates with fewer complications such as sepsis and
bronchopulmonary dysplasia, a chronic lung disease affecting premature infants.
In April 2024, the last patient was enrolled in “The Connection Study,” and in July 2024, the
last patient in the study completed treatment. In August 2024, IBT received the study results,
which showed that the group treated with IBP-9414 had a significant 27% reduction in overall
mortality compared to the placebo group, meaning that widespread use of IBP-9414 could
save more than 1,000 patients annually in the U.S. alone.
The treatment has been designated both a “Breakthrough Therapy” (March 2025) for
gastrointestinal mortality and a “Rare Pediatric Disease,” reflecting its potential to address a
significant unmet medical need.
Common problems in the care of premature infants
Gastrointestinal-related mortality in premature infants is a serious condition and a major
contributing factor to the unacceptably high mortality rate. Infections and inflammation in
these infants cause fatal intestinal damage. Their impaired immune competence makes them