SBIR Phase I:Faecalibacterium prausnitzii supernatant oral formulations to improve insulin sensitivity and treat prediabetes

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to prevent and treat prediabetes and type 2 diabetes. More than 1 in 3 American adults have prediabetes or type 2 diabetes with associated healthcare costs exceeding $327 billion. Current therapies often present adverse effects or are ineffective in some patients. The top five human diabetes drugs alone are expected to cost $23 billion annually by 2024.This project advances a novel diabetic treatment composed of a postbiotic mixture from beneficial gut bacteria. This will improve clinical outcomes for prediabetic patients.This Small Business Innovation Research (SBIR) Phase I project will evaluate the efficacy and elucidate the mechanism of a potential microbiome-based treatment toward an oral treatment that effectively reduces diabetes-associated markers. The three technical objectives are to: 1) evaluate the technology and demonstrate equivalent or superior performance compared to existing antidiabetic drugs, 2) better understand the mechanism that leads to efficacy in the treatment of prediabetes and type 2 diabetes, and 3) identify the active molecule(s) from the postbiotic mixture. These objectives will be carried out using rodent trials, cell-based assays, and advanced separation techniques.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.