IBT received results in August from the largest ever randomized clinical trial in premature infants. During the fall, IBT has continued to review the phase 3 results. Parts of the results have previously been communicated and presented by the study's principal investigator at the Hot Topics conference in Washington DC in early December. IBT has also met with the FDA during this quarter. After the continued review and dialog with the FDA, IBT sees no reasons to discontinue the drug development of IBP-9414 as previously decided.
"It is satisfying that after the reviews in the fall, we will continue towards the launch of our drug IBP-9414 as soon as possible. This is good news for all infants who need our treatment to improve their chances of survival", says Staffan Strömberg, CEO of IBT.
Contacts
Staffan Strömberg, CEO
Maria Ekdahl, CFO
info@ibtherapeutics.com
+46 76 219 37 38
About Us
Infant Bacterial Therapeutics AB ("IBT") is a public company domiciled in Stockholm. The company's Class B shares are since September 10, 2018, listed on Nasdaq Stockholm (IBTB).
IBT is a pharmaceutical company whose purpose is to develop and commercialize drugs for diseases affecting premature babies. During the 12 years of drug development IBT has gained unique expertise in the field of drugs using live bacteria as active substances. This is a key competitive factor for our development programs.
IBT's main focus is the drug candidate IBP-9414, a formulated bacterial strain naturally found in human breast milk. IBP-9414, is expected to be the first product in the new class of biologics called "Live Biotherapeutic Products" for premature infants. The drug development of IBP-9414 is currently in its final stages for this important product for premature babies.
The portfolio also includes additional drug candidates, IBP-1016, IBP-1118 and IBP-1122. IBP-1016, for the treatment of gastroschisis, a life-threatening and rare disorder in which children are born with externalized gastrointestinal organs. IBP-1118 to prevent retinopathy of prematurity (ROP), one of the leading causes of blindness in premature babies, and IBP-1122 to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital infections.
Through the development of these drugs, IBT can address medical needs where no sufficient treatments are available.
