Infant Bacterial Therapeutics AB
IBT is a pharmaceutical company with its registered office in Stockholm with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. IBT is currently developing its lead drug candidate IBP-9414, to prevent NEC and improve feeding tolerance in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. IBT is further pursuing a second rare disease program IBP-1016 for the treatment of an unmet medical need in gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Medical Research
- Market Focus:
- Internationally (various countries)
- Year Founded:
- 2013
Vision and Mission
Vision
IBT is a leading development company that will provide novel therapies influencing the human infant microbiome to prevent or treat diseases.
Premature infants are the most vulnerable beings on the planet and for them to survive, grow and thrive they need intensive and specialized care. Although advances in medical care and handling over the last 30 years have improved survival and well-being of these sensitive infants, both in the immediate post-natal period and in their subsequent lives, current drugs and therapies are mostly designed for adults and are not adapted to this specific and vulnerable patient population. Specific treatment and prophylactic therapy are thus underdeveloped and there is an urgent demand for drugs designed for the unique needs of the premature baby.
IBT has a vision to become an internationally recognized and leading company in the development of therapies to prevent or treat diseases of the premature infants.
Mission
IBT identifies areas of high unmet medical need in premature infants and effectively develops innovative therapies.
IBT develops, and intends to market and sell safe and efficacious therapies well adapted to its purpose that affects infants’ microbiome and thereby prevent or treat rare diseases that affects premature infants. IBT seeks to remain close to the needs expressed by healthcare providers and parents to provide satisfactory therapeutic solutions and continuously improve its offering.
IBT History
2013
- 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
2014
- Pharmaceutical development defining the manufacturing process of IBP-9414
- EMA provides scientific input to IBT development plans
2015
- 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
2016
- 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
2017
- 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
2018
- 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
2019
- 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
2020
- IBT’s clinical study application was approved in Israel in January, in Poland in October and in Bulgaria in November
2021
- IBT’s clinical study application was approved in Serbia in July and in Romania in August