Infant Bacterial Therapeutics (IBT) has started enrolling premature infants in the Phase III Connection clinical trial to evaluate its investigational drug IBP-9414 for the prevention of necrotising enterocolitis (NEC).
IBP-9414 contains a human bacterial strain that occurs naturally in breast milk called Lactobacillus reuteri. It is intended to improve feeding tolerance in premature babies.
The randomised, double-blind and placebo-controlled Phase III trial is designed to assess the safety and efficacy of IBP-9414 in around 2,158 premature infants with a birth weight of 500g to 1,500g.
To be performed at approximately 100 hospitals across the US, Europe and Israel, the trial secured approvals in the UK, France, Hungary and Spain.
An investigational new drug (IND) application is currently open in the US.
Primary outcome measures of the study, which is expected to be completed in December next year, are confirmed necrotising enterocolitis and time to sustained feeding tolerance.
In addition, the trial’s secondary outcomes include at least one clinical sign of necrotising enterocolitis, the number of hospitalisation days, surgery with confirmation of necrotising enterocolitis, weight gain, and days with clinical signs of feeding intolerance.
Infant Bacterial Therapeutics CEO Staffan Strömberg said: “We are pleased to announce ‘first patient in’ in this important Phase III study. It is a milestone for IBT and the study we are now starting marks a significant step in the development of therapies to address major medical needs facing the prematurely born babies.”
The Phase III Connection study is the final trial under IBP-9414’s development programme, which also includes a completed randomised, double-blind, dose-escalation safety and tolerability study.