Infant Bacterial Therapeutics shares topline data of Phase II study of IBP-9414.
M2 PHARMA-September 11, 2017-Infant Bacterial Therapeutics shares topline data of Phase II study of IBP-9414
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Swedish pharmaceutical firm Infant Bacterial Therapeutics and its principal investigator Dr. Josef Neu have made an initial evaluation of the topline data of the Phase II study of IBP-9414, finding a similar safety and tolerability profile in the active and placebo groups, the company reported on Monday.
The randomised, double blind, parallel-group, dose escalation placebo-controlled multicentred study examined the safety and tolerability of IBP-9414 administered in preterm infants.
It included 120 preterm infants, evaluated at various time points leading up to six months after the administration of the drug.
The data suggests a similar safety and tolerability profile in the active and placebo groups, but it will be further examined before it is presented 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," commented CEO Staffan Stromberg.
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|Article Type:||Clinical report|
|Date:||Sep 11, 2017|
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