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After the Data Monitoring Committees’ review Infant Bacterial Therapeutics expands the enrollment criteria of The Connection Study to include 500 - 1000 gram birth weight premature infants.
The Data Monitoring Committee (DMC) has performed a per protocol predefined safety and tolerability assessment of the first 300 patients included in the study. The review is now complete and the DMC has no objections to the continuation of the Connection Study and expansion of the enrolment criteria from 750 to 1000 grams to include 500 to 1000 gram birth weight premature infants. All participating hospitals will be informed immediately of this change. The possibility to recruit infants in the 500 to 749 gram interval adds a significant number of patients eligible for inclusion into the Connection Study.
The DMC is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
“The medical need for preventive treatment for necrotizing enterocolitis and to improve feeding tolerance in preterm infants remains very high. IBT anticipates the completion of the study during 2022 and we expect that the opening up of the US society after their successful vaccination campaign against COVID together with the expansion of the birth weight window will increase the recruitment pace of our important study” says Staffan Strömberg, Chief Executive Officer of IBT.
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (publ) is a pharmaceutical company with a product in 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, for the prevention of necrotizing enterocolitis (“NEC”) and improvement of feeding tolerance in premature infants. IBP-9414 contains the active substance 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.
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s class B-shares shares are listed on Nasdaq Stockholm, Mid-cap (IBT B).
For additional information please contact
Staffan Strömberg, CEO
Daniel Mackey, CFO
Infant Bacterial Therapeutics AB
111 21 Stockholm
Phone: +46 70 670 1226
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 22:00 CET on April 29, 2021.