FDA and IBT seemingly in agreement on Phase III study design
Category: #health  By Paroma Bhattacharya  Date: 2019-05-20
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FDA and IBT seemingly in agreement on Phase III study design

The US Food and Drug Administration (FDA) has reportedly informed Infant Bacterial Therapeutics (IBT) in writing that the company has responded reasonably to its comments pertaining to the Phase III study design and that there are presently no additions from FDA’s side.

On these grounds, claim reports, an assessment of IBP-9414’s effect on the digestive system of premature infants in the upcoming Phase III study is now strategized, since there is no adequate way for premature infants to take up nourishment, reported trusted sources.

As per a previous announcement, IBT has deliberated the pediatric investigation plan (PIP) with the European Medicines Agency (EMA), which lead to IBT’s PIP approval in 2017.

The impending days at IBT’s office will be rigorous, for the company will attempt to receive an approval, before the first half of the year for formal clinical trials required before the first patient can be dosed in the trial. The company also plans to conduct the study in hospitals based in the United Kingdom, France, Israel, Hungary, Spain, and the United States, cited sources familiar with the development.

Staffan Strömberg, CEO of IBT said in a statement that receiving the FDA’s remarks took longer than the anticipated duration, however, now the company has a significantly enhanced protocol opposed to what it had 6 months before. Formerly, the company solely focused on preventing necrotizing enterocolitis, a terrible intestinal disease which affects premature infants and commonly leads to severe outcomes. During the spring of 2019 however, through consultation with the FDA, the company has widened the disease indications, on the basis of which IBT’s drug candidate can expectantly demonstrate an effect, Strömberg added. 

For the record, Infant Bacterial Therapeutics is one of the leading pharmaceutical companies with a product in clinical stage, aiming to develop medications influencing the infant microbiome to avert or treat rare medical conditions affecting infants.

Source Credits: http://ibtherapeutics.com/fda-and-infant-bacterial-therapeutics-agree-on-the-design-of-phase-iii-study/



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Paroma Bhattacharya

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Paroma Bhattacharya

Paroma currently works as a content developer for Algosonline, MSF and a series of alike platforms. Fortified with a post-graduation degree in Journalism and Mass Communication, she delved head long into a writing career, creating resourceful and information enriched ...

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