Presentation

Company Profile
Infant Bacterial Therapeutics (IBT) is a clinical stage pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting infants. It was spun-out from BioGaia in 2016. It is currently developing IBP-9414, a drug candidate to prevent NEC, a fatal disease that affects premature infants. The drug contains the active substance Lactobacillus reuteri, which is a co-evolved human bacterial strain naturally present in breast milk. In addition, IBT is also pursuing a second rare disease program, IBP-1016, for the treatment of gastroschisis, a severe disease occurring in infants. The company is headquartered in Stockholm, Sweden.

Recent highlights
The pivotal Ph3 study with IBP-9414, the “Connection Study”, is ongoing. During Q2 2021, IBT completed the pilot study which the company agreed with FDA to conduct after having recruited 300 patients. The purpose of the pilot study was to validate the second primary endpoint “sustained feeding tolerance”. The result was that the protocol´s selected endpoint confirmed statistical significance and demonstrated also medical relevant effects according to a panel of clinical experts.

Outlook
The improved Covid situation in combination with the expanded inclusion criteria has led to a significant increase in the recruitment rate in the phase 3 study. IBT are thus quickly approaching the next, pre-planned, safety evaluation at 600 patients. IBT expects to reach 600 children in Q3 2021.