Infant Bacterial Therapeutics (IBT) (STO:IBTB) announced on Friday that the US FDA has informed IBT in writing that IBT has responded satisfactorily to the comments that the FDA had regarding the phase III study design for IBP-9414 and that there are currently no additions from the FDA's side.

IBT said that for an extended time, it has consulted with the US Food and Drug Administration (FDA) on how the company's planned phase III study should be designed.

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.

The company has discussed the clinical development plan PIP (paediatric investigation plan) with the EMA (European Medicines Agency), which resulted in IBT's PIP being approved in 2017.

Before the first half of the year and as soon as possible, IBT expects to receive the formal clinical trials approval required before the first patient can be dosed in the study. BT plans to start the study in hospitals in France, Hungary, Israel, Spain, the UK and the US.

Infant Bacterial Therapeutics AB is a pharmaceutical company with a product in clinical stage with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.