After safety review The Connection study is now again open to recruit the smallest infants.
Following the completion of the DMC (Data Monitoring Committee) safety review, IBT is pleased to announce the continuation of the recruitment of patients between 500 – 1000g (Strata A and B) in the Connection study.
“Given the vulnerability of the Stratum A population, infants with a birth weight less than 750 gram, we have agreed with the FDA to carefully monitor the safety of these infants. Therefore, the independent DMC has completed an additional safety review, and there are no objections to continue the study. We expect recruitment to increase as we now again recruit in two strata. ” Says Staffan Strömberg, Chief Executive Officer of IBT.
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 22.30 CET on September 22, 2021.