IBT started to recruit infants in Strata A (weight of 500g-749g) in The Connection Study on April 29 2021. Today, 68 infants have been recruited to the group.
In accordance with the study protocol and clinical observations, enrolment of infants to Strata A has been paused awaiting a safety review by the Data Monitoring Committee (DMC). Subjects already randomized will continue treatment as per protocol, and enrolment of subjects into Strata B (750g-1000g) will continue. IBT is awaiting advice from the DMC before taking any decision regarding further recruitment of infants in Strata A. The DMC is expected to give their opinion in September this year.
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Mid-cap (IBT B).
Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.
IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available
This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 12:50 CET on Aug 25, 2021.