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IBT B - Infant Bacterial Therapeutics AB News Story

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Infant Bacterial Therapeutics announces that the recruitment to the first stage of the Phase III Connection Study is completed - an update about the clinical development of IBP-9414

Wed 10th February, 2021 2:00pm
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Infant Bacterial Therapeutics (IBT) announces that the company has reached an
important milestone after recruiting 300 premature infants to the ongoing
clinical Phase III study of IBP-9414. This in part means that a safety
analysis of these infants will take place in order to also recruit infants
with a very low birth weight, which in turn is expected to significantly
increase the recruitment rate. Furthermore it means that IBT has an
opportunity to validate the study’s second primary endpoint, feeding
tolerance, and redefine this if necessary.

IBTs clinical Phase III study of its drug candidate IBP-9414 for the
prevention of necrotizing enterocolitis and improvement of feeding tolerance
in premature infants, the Connection Study, started in July 2019. There are
currently 68 neonatal intensive care units (NICUs) open for recruitment in the
study. These NICUs are located in France, Hungary, Israel, Spain, the UK and
the USA. The clinical trial application has further recently been approved in
Bulgaria and Poland and submitted in Romania and Serbia. IBT expects that
approximately 20 NICUs will open for recruitment in the coming months in these
newly added countries. 

The majority of the infants intended to be recruited to the Connection Study
will be extremely low birth weight (ELBW) premature infants, i.e they have
birth weights of 1000 grams or below. These are the most vulnerable preterm
infants and as a precautionary measure the study was designed to include 300
infants with birth weights between 750 and 1000 g in the first stage of the
study. After the ongoing safety analysis of these infants the recruitment is
intended to be broadened to include infants with a birthweight down to 500 g.
This is expected to double the number of infants available for inclusion in
the study and we anticipate a significant increase the speed of recruitment in
the study. 

Prior to commencing the Connection Study, IBT agreed with the FDA to perform a
pilot analysis of the first 300 patients with the purpose of qualitatively and
quantitatively assessing the clinical meaning of the premature infants ability
to, as soon as possible, receive enteral feeding without complication.
Together with the external neonatology expert group we will analyze the
correlation between sustained feeding tolerance and, for example, the
incidence of sepsis in the infants. In accordance with the agreement with the
FDA, the purpose of the pilot analysis is to validate the second primary
endpoint of the study and if necessary redefine it.  

At the beginning of 2020 and prior to the COVID 19 pandemic, recruitment rates
were close to those expected and IBT predicted reaching 300 patients during
2020. However, due to the effects of the pandemic, reaching this milestone has
been delayed by a number of months. As previously communicated, IBT now
anticipates to complete the study in 2022. 

Through extensive cooperation with the investigating NICUs, IBT has been able
to mitigate the pandemics effects on recruitment, and patients have been
recruited during the duration of the pandemic. All patients included in the
Connection Study are in-hospital patients and therefore no formal outpatient
visits are required. Due to this, hospital restrictions on visiting have not
affected the Connection Study. Through for example the use of virtual study
monitoring, it has also been possible to maintain study quality in relation to
patient data capture.

The pandemic has however affected recruitment to the study in several ways.
Firstly, certain hospitals stopped recruitment to all clinical research
studies and new studies were not allowed to start as the relevant research
staff were allocated other responsibilities. Further, the staff on duty in the
NICUs have in some cases been transferred to COVID-related intensive care
departments. In addition, neonatologists in the study as well as scientific
journals are reporting a dramatic drop in the numbers of premature infants
born into their NICUs during the pandemic. Recruitment rates are expected to
significantly increase once the pandemic is under control.    

Clinical trial supply is functioning well and the IBP-9414 product is
well-accepted by hospital pharmacies involved in the Phase III study. IBT is
also pleased that the ongoing stability program for the physical product
IBP-9414 is going according to plan. 

The cost estimates for the Connection Study performed prior study start
correspond to the actual incurred expenses. As previously communicated, IBT
estimates that it has sufficient capital to complete the Phase III Study. 

The pandemic has in various ways affected the possibility to recruit patients
to the study, not least when a limited weight group interval range was chosen
as a precautionary measure for the first 300 patients in the study. The first
phase of the study is being evaluated at the same time that we can conclude
that the study quality is sufficient and that the study can be completed with
IBTs current capital. IBT expects that the recruitment rate will increase
during 2021 due to the combination of lower impact from the COVID pandemic,
continued opening and activation of new hospitals and the fact that the study
is expected to include infants with a birth weight down to 500 grams. The
medical need for preventive treatment for necrotising enterocolitis and to
improve feeding tolerance in preterm infants remains very high.

About Infant Bacterial Therapeutics AB
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

IBT is currently developing the drug candidate IBP-9414, for the prevention of
necrotizing enterocolitis (“NEC”) and improvement of feeding tolerance in
premature infants. IBP-9414 contains the active substance 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 fulfill unmet needs for
diseases where there are currently no prevention or treatment therapies

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).

For additional information please contact 
Staffan Strömberg, CEO
Daniel Mackey, CFO
Infant Bacterial Therapeutics AB
Bryggargatan 10
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 the
Securities Markets Act. The information was submitted for publication, through
the agency of the contact persons set out above, at 15:00 CET on February 10,

*     PR 20210210 300pat ENG
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