IBT is currently developing its lead drug candidate IBP-9414 to prevent necrotizing enterocolitis (NEC), and to improve so called 'feeding intolerance' affecting premature infants.
Including an additional indication means having multiple independent endpoints for IBP-9414 and may increase the chances of success in the ongoing Phase III study, 'The Connection Study' and the product's future market potential. IBP-9414 contains Lactobacillus reuteri as an active substance, which is a human bacterial strain found naturally in breast milk.
This message from the CEO is written in early
It has become more difficult to maintain full activity with our suppliers and a greater number of hospitals are affected to a greater extent as the pandemic continues.
Our study is not dependent on 'normal' hospital or doctor visits, since the infants we recruit are already in the intensive care units irrespective of our study. This is essential for the completion of our study as many hospitals have now introduced a ban on non-essential visitors. This is very different from the vast majority of clinical trials conducted globally, which usually require that patients come to clinics to receive the medication as well as for measurements to be performed. As announced in the Annual Report, we have not achieved the expected recruitment rate in the study and it is clear that the pandemic and the 'lock-down' that took place in the
The pandemic has changed our way of working, we cannot travel and have face to face meetings, which means that these activities occur at a distance. For example, hospitals are now activated through virtual meetings.
Our goal to complete the ongoing Phase III study in 2021 remains. We are still recruiting infants in the study, however due to the Corona crisis, there is a risk that we cannot achieve this goal. Thus, there is a not insignificant risk that the study results may be delayed.
IBT's qualified team continues to work in a dedicated and focused manner with the aim of delivering study results which, in turn, hopefully means that a product that really plays a vital role for the premature infants can reach the market as soon as possible.
ABOUT
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 available.
Contact:
Tel: +46 70 670 1226
Email: info@ibtherapeutics.com
Web: www.ibtherapeutics.com
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