Infant Bacterial Therapeutics AB (IBT) whose mission is to develop and commercialize pharmaceuticals for diseases affecting premature babies and BioConnection, a leading pharmaceutical Contract Manufacturing Organisation (CMO), announced the initiation of Process Performance Qualification (PPQ) for the Drug Product (DP) for IBT's lead Live Biotherapeutic Product, IBP-9414. The DP PPQ programme will be conducted at BioConnection's manufacturing facility in Oss, the Netherlands.
Alexander Willemse, CEO at BioConnection, said: " After conducting successful manufacturing tests in close collaboration with the IBT team, we are proud to announce that we are taking the next step together to bring their life-saving product to market. Their innovation aligns seamlessly with our mission to support breakthrough therapies, especially those aimed at protecting premature infants during the most vulnerable stage of their lives. This is what drives BioConnection. With our proven capabilities and flexible setup, BioConnection is ideally positioned to support IBT's continued market expansion and to grow alongside them as a reliable long-term partner."
Staffan Strömberg, CEO at IBT, said: "We recently announced a partnership for the first step in the production process. Now we have secured the second and last step in the manufacturing process for IBP-9414. BioConnection is currently supplying more than a handful of pharmaceutical products to the European and US markets and this makes them an ideal partner for IBT. Having BioConnection as a Drug Product supplier helps us to secure our commercial supply chain going forward."
About BioConnection
BioConnection (BCO) is a specialized contract development and manufacturing organization (specialized CMO) serving the pharmaceutical industry. It specializes in the production of injectable (bio) pharmaceutical products, catering to a global clientele from our FDA and EMA-certified facility in Oss, The Netherlands. Their comprehensive range of services includes Chemistry, Manufacturing, and Controls (CMC), encompassing drug product manufacturing process development, Fill & Finish for liquid products, and freeze-drying (lyophilization) presentations at both clinical and commercial scales in vials and syringes. Additionally, the company offers specialized small-scale (hand fill) production for personalized medicines, ensuring adaptability and precision in pharmaceutical manufacturing.
For more information on BioConnection, please visit www.bioconnection.eu
About IBT
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 mission is to develop and commercialize drugs for diseases affecting premature babies.
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.
In the Phase III "Connection study" in premature infants that was completed in July 2024, the group treated with IBP-9414 demonstrated a significant 27% reduction in all-cause mortality compared with the placebo group, meaning that widespread use of IBP-9414 could save more than 1000 patients annually in the US alone. The therapy has received both "Breakthrough Therapy" designation (March 2025) for gastrointestinal related mortality and "Rare Paediatric Disease" designation, reflecting its potential to address a significant unmet medical need.
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.
Contacts
IBT
Staffan Strömberg, CEO
Maria Ekdahl, CFO
info@ibtherapeutics.com
+46 76 219 37 38
BioConnection
Alexander Willemse, CEO
Richard Sewalt, CCO
info@bioconnection.eu
+31 412 637 937