“IBT announced earlier today that the Data Monitoring Committee (DMC) has performed the planned safety analysis of the study data of 1,403 babies. We have now also received results from the pre-planned futility analysis. It is therefore with great pleasure that I would like to convey that we are continuing with full steam ahead towards the goal of bringing IBP-9414 to the market”, stated CEO Staffan Strömberg.
The positive outcome of the futility analysis indicates that there is a reasonable, predefined chance that Infant Bacterial Therapeutics’ AB (IBT’s) Connection Study will achieve a significant therapeutic effect with respect to the primary endpoint, prevention of Necrotizing Enterocolitis (NEC).
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s Class B shares are since September 10, 2018, listed on Nasdaq Stockholm (IBT B).
IBT is a pharmaceutical company whose purpose is to develop and market drugs targeting diseases affecting prematurely born infants or caused by antibiotic-resistant bacteria.
IBT’s main focus is on its drug candidate IBP-9414, whose development program is designed to demonstrate a reduced incidence of necrotizing enterocolitis (NEC) and whether prematurely born infants achieve improved sustained feeding tolerance (SFT) when treated with the active substance Lactobacillus reuteri, a bacterial strain naturally found in human breast milk. IBP-9414 is currently in an ongoing registration-enabling pivotal Phase III study and is the company’s most advanced development project.
The portfolio also includes drug candidates, IBP-1016, IBP-1118, and IBP-1122. IBP-1016 is for the treatment of gastroschisis, a life-threatening and rare condition where the child is born with externalized abdominal organs. IBP-1118 aims to prevent ROP (retinopathy of prematurity), a leading cause of blindness in premature infants, while IBP-1122 aims to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital acquired infections.
By developing these drugs, IBT has the opportunity to address medical needs where no available treatments currently exist.
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 17:20 CET on June 21, 2023.