5-10% of the smallest premature infants develop necrotizing enterocolitis (NEC), a potentially lethal disorder in which portions of the bowel undergo tissue death. A key goal in the treatment of preterm infants is achievement of full enteral feeding as early as possible to optimize growth (and to improve longer term clinical outcomes).

To ensure adequate production quality and to assess the risks and benefits of medicines that treat a disease, drugs must be approved by a regulatory medicines agency before use. This review is particularly important given the vulnerability of the preterm babies. IBT is committed to develop a first in class New Biological Entity (NBE) for this vulnerable population by following the agency requirements.

The Connection study is a regulatory medicines agency approved phase 3 study on the potential benefits of the New Biological Entity (NBE), IBP-9414, in premature infants.