For an extended time, IBT has consulted with the US FDA on how the company’s planned Phase III study should be designed.
IBT announced the FDA has now informed IBT in writing that IBT has responded satisfactorily to the comments that the FDA had regarding the study design and that there are currently no additions from the FDA’s side.
As a consequence of the FDA’s comments, an evaluation of the effects of IBP-9414 on the digestive system of premature infants in the forthcoming Phase III study is now planned, as a serious medical problem for premature infants is that they cannot take up nourishment in an adequate way.
As previously announced, IBT has discussed the clinical development plan PIP (pediatric investigation plan) with the EMA (European Medicines Agency), which resulted in IBT’s PIP being approved in 2017.
IBT hopes to receive the formal clinical trials approval before the end of the first half of the year. As previously announced, IBT plans to start the study in hospitals in France, Hungary, Israel, Spain, the United Kingdom, and the United States.
“Receiving the FDA’s comments took longer than we expected, but now we have a greatly improved protocol compared to what we had 6 months ago. Previously, our only focus was on preventing NEC (necrotizing enterocolitis), that in itself is a terrible intestinal disease which impacts premature infants and too often leads to fatal outcomes. During the spring of 2019, through consultation with the FDA, we have broadened the disease indications on which our drug candidate can hopefully demonstrate an effect,” says CEO Staffan Stromberg.