IBT has previously announced its plan to start the phase 3 study in the first half of 2018. Preparations for the study have taken slightly longer than expected and the Company now plans to initiate the phase 3 study in the second half of 2018. The Company still expects to meet the previously communicated timeline for application for registration of the drug, which is expected to take place in 2020, given a positive outcome in the Company's phase 3 study.
Preparation for IBT's final phase 3 study continues, which means that the Company has ongoing intensive contact and dialogue with authorities, a large number of testing centers, key opinion leaders, the Company's CRO (Clinical Research Organization) and contract manufacturers.
IBT has chosen to contract Premier Research, the Company's CRO during its phase 2 study, to also conduct the phase 3 study. The choice of Premier Research was made after a comprehensive and long competitive procurement process and is based on their favorable terms and their successful participation in the completed phase 2 study.
"The process of preparing our phase 3 study in which we will recruit over 2,000 premature infants, the largest study ever conducted on premature infants, is extensive and consists of many complicated components. We have come a long way in our preparations and are very pleased to have been able to come to agreement with Premier Research, "says Staffan Strömberg, CEO IBT.
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (publ) (“IBT”) is a clinical stage pharmaceutical company with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.
IBT is currently developing its lead drug candidate IBP-9414 to prevent NEC in premature infants. IBP-9414 contains the active substance Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. IBT is further pursuing a second rare disease program IBP-1016 for the treatment of an unmet medical need in gastroschisis, a severe congenital disorder in infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.
IBT is listed on Nasdaq First North Premier with Erik Penser Bank as Certified Adviser.