The ‘Connection Study’ on the pharmaceutical grade probiotic IBP-9414 has two independent primary endpoints- the incidence of Necrotizing Enterocolitis (NEC) and the time to a strict definition of Sustained Feeding Tolerance (SFT). SFT is important to reach as early as possible and a critical goal in the neonatal intensive care (NICU) treatment of premature infants.
Treatment- blind evaluation of the first 641 infants completing the study with use of quantitative statistics revealed significant delays in the time to reach SFT for 23 examined clinical events characteristic of the NICU treatment of premature infants*. The greatest delay occurred in infants with gastrointestinal perforation, hypotension, serious cardiac events and pneumonia (mean delays of 10.1-20.0 days). The time to SFT also strongly influenced the duration of NICU stay and was associated with events like NEC, retinopathy of prematurity, late onset sepsis and days on antibiotics for systemic use.
This further builds on the previously published data** showing that even a one-day reduction in time to SFT correlates to several clinically meaningful outcomes including reductions in NEC, late onset sepsis, bronchopulmonary dysplasia and antibiotic use.
“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 unveils in hitherto unknown detail the importance of reaching a full enteral feeding, being vital to the short and long term development of the premature infant. I like to emphasize that this is really promising data that further 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.
*Guthrie SO, Neu J, Doctor B, et al. Association of clinical events to the time to a strict definition of sustained feeding tolerance in premature infants in the ‘Connection Trial’. Br J Gastroenterol. 2022; 4, 264-72.
**Neu J, Del Moral T, Ferry J, et al. Clinical outcomes correlating to a one-day shift in sustained feeding tolerance in very low birth weight infants in the ‘Connection Trial’. Br J Gastroenterol. 2022; 4, 255-60.
For the full article, please refer to: https://britishjournalofgastroenterology.com/wp-content/uploads/2022/04/BJG-134.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 supporting 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 IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants, IBP-1118 to prevent ROP (retinopathy of prematurity), a growing and serious condition that can lead to blindness among prematurely born babies and IBP-1122 to prevent antibiotic resistant hospital acquired infections. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no sufficient prevention or treatment therapies available.