IBT is a clinical stage pharmaceutical company with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.
IBT is developing drug candidate IBP-9414 to prevent necrotizing enterocolitis (NEC), a devastating and often fatal disease in premature infants. IBP-9414 contains the active substance Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. IBT has an additional project in its portfolio, 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.
Prior to his current assignment, Eamonn Connolly, Chief Scientific Officer at IBT, extensively developed the research around Lactobacillus reuteri at BioGaia for 15 years. Over the years, he noted increasing demands and interests of clinicians around the world in the use of Lactobacillus reuteri in premature infants for the prevention of NEC. BioGaia’s products are however not intended for premature infants nor are the drugs indicated for a specific disease. When Staffan Strömberg (CEO of IBT) joined BioGaia, he and Eamonn Connolly saw the opportunity with their extensive pharmaceutical experience to answer this particular unmet medical need with a pharmaceutical approach and more specifically an orphan drug. Together with Staffan Strömberg and Eamonn Connolly, BioGaia commenced the operations of a BioGaia subsidiary, namely IBT, in 2013 which would focus exclusively on the development of drugs for premature infants, thereby differentiating from its former parent company BioGaia.
On 18 March 2016, BioGaia resolved on a separation of IBT On 29 March 2016, IBT’s series B shares were admitted to trading on Nasdaq First North.
On 18 March 2016, BioGaia resolved on a separation of IBT through a distribution of all of BioGaia’s shares in IBT to the shareholders of BioGaia, applying the Lex ASEA rules. On 29 March 2016, IBT’s series B shares were admitted to trading on Nasdaq First North.
In June 2016, IBT commenced the randomized, double blind, parallel-group, dose escalation placebo- controlled multi-center study to investigate the safety and tolerability of IBP-9414 administered in preterm infants. On 11 September 2017, IBT reported the preliminary results from this safety and tolerability study. This study included 120 premature infants in total, with birth-weight ranging from 500 to 2,000 grams. The results demonstrate a similar safety and tolerability profile in the active group as in the placebo group.
In September 2017, the Paediatric Committee (PDCO) at the EMA adopted a positive opinion on the Paediatric Investigation Plan (PIP) proposed by IBT for the development of IBP-9414 for the prevention of NEC. The PIP is a prerequisite for IBT to move forward with the clinical development plan for IBP-9414. Compliance to an agreed PIP adds a two-year extension to the 10-year market exclusivity awarded to an orphan designated product (such as IBP-9414) at market approval in the EU.