IBT is currently developing its lead drug candidate IBP-9414 to prevent necrotizing enterocolitis (NEC), and to improve so-called 'feeding tolerance' in premature infants.
IBP-9414 contains Lactobacillus reuteri as an active ingredient, which is a human bacterial strain found naturally in breast milk.
This message from the CEO is written during the continuing COVID-19 pandemic which has been ongoing for almost nine months. The pandemic not only affects our work at IBT but of course also the staff at the hospitals where our study is ongoing. Right now, in
As I mentioned earlier, we have managed to change our way of working in order to ensure the quality of our study by, amongst other things, carrying out so-called virtual monitoring and providing testing material to all recruiting hospitals despite the ongoing COVID pandemic. We have previously communicated that in order to increase the recruitment rate, we have applied to start our clinical study in four more European countries,
We monitor our study on a regular basis and we can today confirm that the study generates data in the way we predicted. Specifically, we see, among other things, good compliance with the protocol, e.g. administration of the study drug and that the reporting system for clinical observations works well and as expected. We have also carried out two pre-planned safety-oriented interim analyses. The outcome of these analyses is that we continue the study as planned. We also have a planned pilot sub-study regarding 'feeding tolerance' which includes data from 300 infants in the current study. Preparations for the analysis in this sub-study are ongoing.
IBT has strengthened its organization by hiring a clinical project manager and a CMC (Chemistry, Manufacturing and Controls) manager. Both of these recruits add significant competence to the organization, which ensures that we can better meet future challenges.
IBT's qualified team continues to work in a dedicated and focused manner to deliver study results which in turn hopefully means that a product, which could play a vital role for the well-being of premature infants, can reach the market as soon as possible. Today, no drug against NEC exists on the market, and as far as is known to IBT, no other company has any ongoing clinical study for a potential pharmaceutical to prevent, alleviate or cure NEC. IBT thus has a substantial edge over other possible future players in the market.
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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