IBT is pleased to announce today's opening of the additional cohort, having included 1,400 premature infants of the total 2,158 recruitment target. Up until now, and per the protocol agreed with regulatory authorities, the Connection Study has recruited infants with birth weights between 500 grams to 1,000 grams. Now with 1,400 recruited infants, the study expands to also include infants with a birth weight between 1,001 grams and 1,500 grams. This is expected to increase the recruitment momentum, increasing the company’s confidence in the current target recruitment timelines.
IBT continues to break new ground in its mission to deliver the first pharma grade probiotic to prevent life-threatening disease of premature infants such as NEC and to promote healthy growth and development by improving feeding tolerance. In 2014, IBT became the first company in the world to receive US Orphan Drug Designation for the prevention of NEC and, in 2018, the first company to receive FDA approval to administer live bacteria to infants in a Phase III clinical trial in the US, called the Connection Study. IBT’s unique ability to develop pharmaceutical grade probiotics was further validated by the permission to expand the Connection Study globally to 10 countries across EU, USA and Israel.
“This milestone is another important step towards concluding our aim to prevent life threatening infant diseases. As part of planning for success we have, in parallel to recruitment and planning for submission for market approval, extended our focus to include ensuring market awareness of our product, the patients access to it and reimbursement for IBP-9414 upon its anticipated market entry.” says Staffan Strömberg, CEO of IBT.
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Small-cap (IBT B).
Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.
IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by supporting sound stomach-and bowel development in premature infants. IBP-9414 contains the active compound L. reuteri, which is a human bacterial strain naturally present in breast milk. The drug candidate portfolio also includes IBP-1016, for the treatment of gastroschisis, a severe and rare serious gastrointestinal malformation affecting infants, IBP-1118 to prevent ROP (retinopathy of prematurity), a growing and serious condition that can lead to blindness among prematurely born babies and IBP-1122, to prevent antibiotic resistant hospital acquired infections. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently not sufficient prevention or no treatment therapies available.
For additional information please contact
Staffan Strömberg, CEO
Infant Bacterial Therapeutics AB
Bryggargatan 10 111 21 Stockholm
Phone: +46 76 219 37 38