The two independent primary endpoints of the ‘Connection Study’ are the incidence of NEC and the time to SFT.
SFT a composite endpoint defined as the first day of tolerating daily enteral feeds of at least 120 ml/kg body weight with no use of parenteral nutrition and with at least 10g/kg in average daily body weight increase, all of which should be maintained for a sustained period of time.
A blinded evaluation of IBT’s Connection Study data shows that even a one day reduction in time to SFT correlates to several clinically meaningful outcomes including a
7.65% reduction in confirmed Necrotizing Colitis (NEC) events
6.71% reduction in late onset sepsis
2.75% reduction in bronchopulmonary dysplasia (BPD)
5.85 reduction in days with antibiotic use
This blinded evaluation of extremely low birth weight infants introduces a strict definition of SFT and underlines the clinical relevance of a one-day change in the time to SFT in premature infants.
“IBT is pioneering pharma grade probiotic development with the aim to prevent life threatening infant diseases. We are very pleased to see that data from our study correlates to benefits in serious and sometimes deadly infant conditions.I like to emphasize that this is really interesting and promising data that validates our study design. Given that this is a blinded evaluation it is not intended to and can not provide any information on the efficacy of our study drug”. says Staffan Strömberg, CEO of IBT.
For the full article, please refer to: https://britishjournalofgastroenterology.com/wp-content/uploads/2022/04/BJG-132.pdf
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, Small-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 sound 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.
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s class B-shares shares are listed on Nasdaq Stockholm, Small cap (IBT B).
For additional information please contact
Staffan Strömberg, CEO
Infant Bacterial Therapeutics AB Bryggargatan 10
111 21 Stockholm
Phone: +46 76 219 37 38