Based on positive Phase II data, the first-in-class antibiotic candidate ibezapolstat for C. difficile is expected to advance to Phase III trials more quickly.
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The largest safety evaluation of any microbiota-based live biotherapeutic includes data for up to two years for the first approved microbiome-based treatment for recurrent Clostridioides difficile (C. diff).
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
This article from the global consulting firm Charles River Associates (CRA) describes how manufacturers must address and overcome three key barriers hindering progress in the microbiome sector and the optimal strategies needed to demonstrate the value of microbiome-based therapies in successful commercialisation.
There is a growing adoption of metabolomics to support drug discovery and development. Metabolomics involves the comprehensive analysis of metabolites in biological specimens. As such, it is commonly used for the discovery and validation of biomarkers that can support critical decisions in the drug development process. In this article, Christopher…