Positive recommendation from the independent Data Safety Monitoring Board to continue Phase II Study
IBT announces that the second and last planned evaluation of safety data by the independent Data Safety Monitoring Board (DSMB), in the ongoing Phase II clinical study, was performed on November 18th. The DSMB concluded that there were no objections to dose escalation into the final cohort of the smallest premature babies, who will be dosed with the highest dose of IBT´s drug candidate IBP-9414.
“We are very pleased that we now have 90 of the 120 premature babies recruited and that the study is progressing according to plan. This is another major milestone in the development of a new pharmaceutical for this very sensitive group of patients”, says Staffan Strömberg, CEO IBT.
The Phase ll trial is a randomized, double blind, parallel group, dose escalation, placebo-controlled multicenter study to investigate the safety and tolerability of IBP-9414 administered in preterm infants. The multicenter trial is being conducted in a number of neonatal intensive care units in the US and will enroll 120 premature infants in total.
For additional information please contact
Staffan Strömberg, CEO, phone: +46 8 410 145 55
Infant Bacterial Therapeutics AB
Bryggargatan 10
111 21 Stockholm
Phone: +46 8 410 145 55
See Press Release in both English and Swedish
November 21, 2016