In our previous quarterly report we were able to announce that the first patient had been recruited in our clinical phase III-study. This study is operationally the most significant in IBT’s operations and therefore I choose to provide some detailed information regarding the study. The study is randomized, double blind and placebo controlled to evaluate the safety and efficacy of IBP-9414 with respect to the prevention of necrotizing enterocolitis and other clinically important aspects of feeding preterm babies.
Our assumptions regarding patient recruitment are based on experience from the concluded phase II study which IBT conducted at 15 clinics in the U.S. during 2017. We currently have approval for conducting the phase III study in France, Spain, The U.K., Hungary and the U.S. and have recruited patients in both Europe and in the U.S. As of the date of this report 37 centers of the 100 planned have been contracted and work is ongoing to contract more. We have not yet initiated recruitment in the UK, while in e.g. Spain recruitment is progressing above expectations at centers which have initiated recruitment.
Meetings held with study doctors during recent weeks have provided awareness of the difficulties of interpreting the inclusion and exclusion criteria described in the study protocol. Therefore, we revised and clarified these criteria during October rendering them more aligned with those used in our phase II study.
We are not satisfied that the study has had a slow start at certain clinical centers, but we also note that other centers are recruiting well, i.e. above expectations. We shall therefore further strengthen the clinical department at IBT in order to ensure that “best practice” is relayed from the centers with superior recruitment to those hospitals which have not initiated as planned. I expect the study to be concluded during 2021 based on the experience we gained from the phase II study. We will therefore further intensify our work with patient recruitment.
November 7, 2019
Chief Executive Officer
Infant Bacterial Therapeutics AB (publ) is a pharmaceutical company with a product in clinical stage with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.
IBT is currently developing the drug candidate IBP-9414, for the prevention of necrotizing enterocolitis (“NEC”) and improvement of so called feeding tolerance in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s class B-shares shares are listed on Nasdaq Stockholm, Mid-cap (IBT B).
Staffan Strömberg, CEO
Daniel Mackey, CFO
Infant Bacterial Therapeutics AB
111 21 Stockholm
Phone: +46 70 670 1226
This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation and which is to be made public according to the Nasdaq regulations for companies listed on Nasdaq Stockholm. The information was submitted for publication, through the agency of the contact person set out above, at 8.00 CET on November 7, 2019.