IBT is currently developing its lead drug candidate IBP-9414 to prevent NEC in premature infants.
IBP-9414 contains the active substance Lactobacillus reuteri, which is a co-evolved human bacterial strain naturally present in breast milk. Lactobacillus reuteri is a live bacteria known to be anti-inflammatory, anti-pathogenic and beneficial to gut motility. IBP-9414 is formulated with close considerations of age-appropriateness of the vulnerable target population of preterm infants.
IBT was granted Orphan Drug Designation by the FDA for Lactobacillus reuteri for the prevention of NEC in premature infants in 2013 and by the European Commission for IBP-9414 including Lactobacillus reuteri for the prevention of NEC in premature infants in 2015. IBT also received Rare Pediatric Disease Designation from FDA for IBP-9414 in 2016, meaning that IBT may be awarded a priority review voucher following market approval.
In June 2016, IBT commenced the Safety and Tolerability study. In late 2017, the results demonstrated a similar safety and tolerability profile in the active group as in the placebo group.
The pivotal Phase III study, the Connection study, commenced July 4, 2019.