IBT | IBT History

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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

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

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
At IBT’s FDA meeting following the conclusion of the phase II study, the FDA recommended that sustained feeding tolerance (SFT) should be measured as a second primary endpoint in the upcoming phase III study.

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, IBT communicated that an agreement with the FDA had been reached forhow to measure sustained feeding tolerance (SFT) in the phase III study. This definition was added into the study design.
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

The COVID–19 pandemic affects the company’s development work, for example, activation of hospitals, which has not occurred at the desired rate. As of the date of the 2020 annual report, more than half of the planned hospitals have been activated. IBT’s cash position is sufficient to carry out the ongoing Phase III study, even if recruitment in the study currently does not take place at the desired rate
IBT’s clinical study application was approved in Israel in January, in Poland in October and in Bulgaria in November

IBT validated sustained feeding tolerance (SFT), according to previous agreement with the FDA. This implies that the phase III study has two validated primary endpoints.
Recruitment of patients in IBT’s phase lll–study is strongly affected by the pandemic. A likely scenario, assuming that the current recruitment level can be maintained, is that the study can be concluded at the end of 2023. Should the pandemic situation once again get worse, recruitment may require additional time. However, the pandemic does not affect the quality in our data or the possibility to conclude the study. Costs are primarily related to the number of patients in the trial, which means that IBT’s liquidity is continuously deemed sufficient to conclude the study.

On January 19, IBT announced that The Connection Study continues after the Data Monitoring Committee (DMC) had completed its pre–scheduled safety analysis without any concerns. At the same time a futility analysis was performed. Based on DMC recommendations and futility outcome, IBT is continuing the recruitment to the study as planned.
On September 23, the FDA approved IBT’s request for a new orphan drug designation for ROP (retinopathy of prematurity).
IBT published in the British Journal of Gastroenterology in October an article based on IBT’s “Connection Study” which demonstrates that sustained feeding tolerance (SFT) is linked to serious disease progression including sepsis and bronchopulmonary dysplasia, validating the study design. It also highlights the potential to reduce healthcare costs with fewer treatment days in the hospital.
IBT negotiated during 2022 the exclusive access to a drug platform that can prevent antibiotic–resistant hospital acquired infections.