A blinded assessment of the IBT Connection Study will be presented by Professor Josef Neu, University of Florida, during the 2021 Neonatal Hot Topics® on December 6, 2021. The assessment reveals that even a Modest reduction in time to sustained feeding tolerance (SFT) correlates positively with several clinically significant outcomes, including sepsis and bronchopulmonary dysplasia, a chronic lung disease that affects premature infants.
Because IBT’s IBP-9414 is the first in its class, no validated endpoint has been established for SFT, the second primary endpoint of the connection study. Before launching the study, the IBT and the FDA therefore agreed on an appropriate validation procedure, the result of which has now been presented by Professor Josef Neu.
IBT’s Phase III clinical study of the drug candidate IBP-9414 for the prevention of necrotizing enterocolitis (ENC) and the improvement of SFT in premature infants began in July 2019 (NTC02472769 ClinicalTrials.gov ). The evaluation presented by Dr. Neu assessed the impact on clinical outcomes associated with a one-day reduction in SFT time. Data were consolidated from 439 premature newborns randomized less than 32 weeks gestation. Of these, 248 (78%) said time spent at SFT was defined as a combination of:
- Enteral feeding at ≥120 ml / kg / day for 10 consecutive days.
- No use of parenteral nutrition for 10 consecutive days.
- The average body weight gain is 10g / kg / day during these days.
The evaluation confirmed that several unfavorable clinical outcomes correlate positively with a reduction in SFT time. This suggests that SFT may be used as a predictor of adverse outcomes in very low birth weight premature infants.
“IBT is a pioneer in the development of pharmaceutical grade probiotics with the goal of preventing life-threatening childhood illnesses and promoting healthy gastrointestinal development. We are very pleased to see the validation results presented by Professor Neu, giving us two main endpoints validated in our study. says Staffan Strömberg, CEO of IBT.
The Scientific Poster presented during the conference is available via this link:
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (IBT) is a stock 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 clinical phase III product 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 of IBP-9414 is to become the world’s first approved probiotic drug to prevent life-threatening illnesses in premature infants, including NEC and sepsis, by promoting healthy development of the stomach and stomachs. intestines 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 serious and rare disease affecting infants. By developing these drugs, IBT has the potential to address unmet needs for diseases for which there is currently no preventive or treatment available.
For more information, please contact
Staffan Strömberg, CEO
Infant Bacterial Therapeutics AB
111 21 Stockholm
Telephone: +46 8 410 145 55
PR 20211206 HotTopics EN