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(September 11, 2017)
Infant Bacterial Therapeutics and the principal investigator Dr. Josef Neu have made an initial evaluation of the top line data of the Phase II "Randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of IBP-9414 administered in preterm infants" (NTC02472769 ClinicalTrial.gov). The study included 120 preterm infants, evaluated at time points up to 6 months after administration of the study drug at 15 neonatal centers in the US. Top line data demonstrate similar safety and tolerability profile in the active and placebo groups.
The data will be further studied during the coming months and the plan is to submit results of the study for presentation at Hot Topics in Neonatology, Washington DC on 10/11 December 2017.
"We are encouraged by the data from this study and the planning for the pivotal Phase III study is continuing. I am also happy that we have been able to run the study according to plan in terms of recruitment, timelines and budget", says CEO Staffan Strömberg.
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (publ) ("IBT") is a pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Using its extensive experience in live bacterial therapeutics and its well-developed knowledge of the action of Lactobacillus reuteri, IBT is developing its lead drug candidate IBP-9414, to prevent necrotizing enterocolitis ("NEC"), a fatal, rare disease that afflicts premature infants. The FDA and the European Commission have granted IBT Orphan Drug Designation, and the FDA have granted Rare Pediatric Disease Designation for IBP-9414 for the prevention of NEC.
IBT is further pursuing a second rare disease programme 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 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.
This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation and which is to be made public according to the Nasdaq regulations for companies listed on Nasdaq First North. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on September 11, 2017.
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