Infant Bacterial Therapeutics Delays Ph III Start Date After Meeting with FDA

• Trial expected to start in 1H2019
• Improved protocol may allow for additional claims

Following its meeting with the US Food and Drug Administration (FDA) in Washington DC to discuss the design of the company’s clinical development program, IBT has chosen to modify its Phase III study of IBP-9414 for the prevention of necrotizing enterocolitis (NEC) in premature infants. With guidance from the FDA, IBT will improve the protocol which may allow additional claims such as reduction in “feeding intolerance”, that could increase the market potential of the product and the chances of success in the company’s Phase III study.

Because of these changes, the Phase III study protocol will not start in 2018 as previously communicated but is expected to start during the first half of 2019. Preparations for this study, including the production of clinical trial material and the initiation of clinical sites in Europe and the US, continue and are unaffected by this FDA meeting.

IBT is developing drug candidate IBP-9414 to prevent necrotizing enterocolitis (NEC), a devastating and often fatal disease in premature infants. IBP-9414 contains the active substance Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. IBT has an additional project in its portfolio, a second rare disease program, IBP-1016, for the treatment of an unmet medical need in gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.