Ad hoc-Mitteilungen

A Blinded Evaluation of the Connection Study – Sustained Feeding Tolerance (SFT) Correlates to Clinical Outcomes

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A blinded evaluation of IBT’s Connection Study will be presented by Professor Josef Neu, University of Florida, at the 2021 Hot Topics in Neonatology® on December 6, 2021. The evaluation reveals that even a modest reduction in time to Sustained Feeding Tolerance (SFT) correlates positively to several clinically meaningful outcomes including Sepsis and Bronchopulmonary Dysplasia, a chronic lung disease that affects premature newborns.

Given that IBT’s product IBP-9414 is first in class, there were no validated endpoints established for SFT, the Connection Study’s second primary endpoint. Prior to initiating the study, 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 Clinical Phase III study of the drug candidate IBP-9414 for the prevention of necrotizing enterocolitis (NEC) and improvement of SFT in premature infants, started in July 2019 (NTC02472769 ClinicalTrials.gov). The evaluation presented by Dr. Neu assessed the impact on clinical outcomes related to a 1-day reduction in time to SFT. Data was consolidated from 439 randomized preterm newborns at <32 weeks gestation. Of these, 248 (78%) reported time to SFT defined as the combination of:

  • Enteral feeding at ≥120 ml/kg/day for 10 consecutive days.
  • No use of parenteral nutrition for 10 consecutive days.
  • Average body weight gain is ≥10g/kg/day during these days.

The evaluation confirmed that several clinically adverse outcomes correlate positively to a reduction in time to SFT. This infers that SFT may be used as a predictor for adverse outcomes in very low birthweight preterm infants.

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