IBT | About IBT

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IBT is a pharmaceutical company whose purpose is to develop and market drugs targeting diseases affecting prematurely born infants or caused by antibiotic-resistant bacteria.

IBT’s main focus is on its drug candidate IBP-9414, whose development program is designed to demonstrate a reduced incidence of necrotizing enterocolitis (NEC) and whether prematurely born infants achieve improved sustained feeding tolerance (SFT) when treated with this New Biological Entity (NBE). IBP-9414 is currently in an ongoing registration-enabling pivotal Phase III study and is the company’s most advanced development project.

The portfolio also includes drug candidates, IBP-1016, IBP-1118, and IBP-1122. IBP-1016 is for the treatment of gastroschisis, a life-threatening and rare condition where the child is born with externalized abdominal organs. IBP-1118 aims to prevent ROP (retinopathy of prematurity), a leading cause of blindness in premature infants, while IBP-1122 aims to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital acquired infections.

By developing these drugs, IBT has the opportunity to address medical needs where no available treatments currently exist.

Eamonn Connolly, previously 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.