“In June we announced that the first premature infant had been enrolled and dosed in the Company´s Phase ll clinical trial. This 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. The first planned independent Data Safety Monitoring Board (DSMB) evaluation of safety data was performed on August 12th. The DSMB concluded that there were no objections to dose escalation based on the information provided to the DSMB.
We are very pleased that the trial has begun and is progressing according to plan. This is another major milestone in the development of a new pharmaceutical for this very sensitive group of patients.”
Chief Executive Officer
Staffan Strömberg, CEO, phone: +46 8 410 145 55
Peter Rothschild, Chairman of the Board, phone: +46 8 410 145 55
Infant Bacterial Therapeutics AB
111 21 Stockholm
Phone: +46 8 410 145 55
The information in this Interim Report is such which IBT 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, by the CEO stated above, at 08.00 a.m. CET on 19 August, 2016.
Interim report January 1 – June 30 2016