Presentation

Infant Bacterial Therapeutics (IBT) is a Swedish pharmaceutical company with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. The company was spun-out from BioGaia in 2016. The lead drug candidate IBP-9414 contains the active compound Lactobacillus reuteri and is currently in clinical Ph3. The aim for IBP-9414 is to become the first approved probiotical drug to prevent life threatening diseases in premature infants, including necrotising enterocolitis (NEC) and sepsis.

Recent highlights
The pivotal Ph3 study with IBP-9414, “The Connection Study”, is ongoing. In January, IBT announced that the Ph3 study continues after the Data Monitoring Committee (DMC) had completed its pre-scheduled safety analysis without any concerns. At the same time a futility analysis was performed. Based on DMC recommendations and futility outcome, IBT is continuing the recruitment as planned. As of May, the study has recruited 915 patients. During Q1, IBT also initiated preparations for commercialization phase of IBP-9414. Additionally, IBT has also started the gastroschisis project (IBP-1016) with, including a key opinion leader meeting in April.

Outlook
The company’s focus is to advance recruitment of The Connection Study towards conclusion. While the study continues, the company will also make sure that it stands ready to launch IBP-9414 under the most expedited scenario. The company expects to be able to complete recruitment in 2023 with existing capital.