This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $300,000 to Biotherapeutics, Inc. to accelerate the development of a novel, antimicrobial-free therapeutic for treating Clostridioides difficile infection (CDI). The key objectives are to:
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Evaluate the comparative efficacy of Biotherapeutics' new product candidate versus FDA-approved CDI therapeutics in mouse models, assessing metrics such as weight loss, disease activity, and gut microbiome modulation.
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Compare the effects of the new product candidate versus current CDI treatments on gut microbiome composition and diversity, as well as the abundance of C. difficile-resistant bacterial strains.
The expected outcomes are a 30% decrease in histopathological scores, 40% reduction in Th17 cell infiltration, and 60% increase in microbiome alpha diversity compared to standard of care. The project aims to generate data to support advancing the new therapeutic into IND-enabling studies and an eventual Phase I clinical trial for treating CDI by 2024.
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