IBT Corporate Facts



  •     IBT is founded as a subsidiary to BioGaia and commences the development of a preventive therapy (IBP-9414) against NEC using Lactobacillus reuteri
  •     IBT is granted Orphan Drug Designation by the FDA for Lactobacillus reuteri for the prevention of NEC in premature infants
  •      FDA provides scientific input to IBT development plans



  •      Pharmaceutical development defining the manufacturing process of IBP-9414
  •      EMA provides scientific input to IBT development plans



  •     IBT is granted Orphan Drug Designation by the European Commission for IBP-9414 including Lactobacillus reuteri for the prevention of NEC in premature infants
  •     Production of drug candidate IBP-9414 according to all applicable pharmaceutical chemistry-manufacture-control regulations for the safety and tolerability study
  •     Active IND obtained from FDA for start of Safety and Tolerability clinical trial in 2016
  •     IBT received approval from the MPA to conduct a clinical trial in Sweden



  •     Separation of IBT from BioGaia
  •     Listing on Nasdaq First North
  •     IBT receives Rare Pediatric Disease Designation from FDA for IBP-9414
  •     IBT adds new indication for Gastroschisis IBP-1016



  •     IBT’s share of series B is traded on First North Premier
  •     IBT completes IBP-9414 safety and tolerability trial and announces that top line data demonstrate similar safety and tolerability profile in the active and placebo groups
  •     EMA adopts a positive opinion on the Pediatric Investigational Plan proposed by IBT for the development of IBP-9414 for the prevention of NEC



  •     The EGM on January 8 decided on a new share issue amounting to SEK 439.1m and as of January 31the share issue was fully subscribed. The share issue in combination with the directed share issue in November of 2017 generated approximately SEK 543.6m prior to transaction costs
  •     In June 2018, IBT contracted Premier Research International LLC, the company’s CRO during the Phase II clinical trial, to also conduct the company’s Phase III clinical trial
  •     IBT series B shares are traded on Nasdaq Stockholm, Mid Cap
  •     IBT has, resulting from discussions with the FDA chosen to modify its Phase III study for the prevention of necrotizing enterocolitis (NEC) in premature infants. Following the guidance from the FDA, IBT will improve the protocol which may allow additional claims such as improvement of “feeding tolerance”, that could increase the chance of success in the Company’s Phase III study and the market potential of the product



  •     IBT signed its first distribution agreement on March 5, 2019, for its product IBP-9414, with MegaPharm Ltd. for the Israeli market and the Palestinian Authority’s territories
  •     On May 19, 2019, it was announced that IBT had responded satisfactorily to the comments that the FDA had regarding the study design to the companies planned Phase III Study which led to the approval of IBTs IND (Investigational New Drug) application. As a consequence of the FDA’s comments, an evaluation of the effects of IBP-9414 on the digestive system, or so called “feeding tolerance” of premature infants in the ongoing Phase III study is now included
  •     During 2019 IBT’s application for clinical trial was also approved in the UK, France, Hungary and Spain
  •     IBT announced on July 4, 2019 that the first patient had been recruited in the company’s pivotal clinical Phase III study, The Connection Study



  • IBT’s clinical study application was approved in Israel in January, in Poland in October and in Bulgaria in November



  • IBT’s clinical study application was approved in Serbia in July and in Romania in August