This $673,379 federal Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), supports the development of a novel, orally administered synthetic biology-based immunotherapy for treating ulcerative colitis. The funding enables biotechnology company Rise Therapeutics LLC to advance its lead probiotic-based drug candidate, R-3750, toward Phase 2 clinical trials. The product leverages engineered Lactococcus lactis bacteria to deliver the anti-inflammatory protein Surface Layer Protein A (SLPA) and regulate gut immune responses. The project aims to establish GMP manufacturing capabilities, conduct clinical manufacturing of the drug substance, prepare the drug product for distribution, and obtain FDA approval to initiate a Phase 2 study evaluating the safety and efficacy of R-3750 in ulcerative colitis patients. This work builds upon prior successful preclinical and Phase 1 clinical results demonstrating the potential of this novel immunotherapy approach to reduce inflammation, strengthen the intestinal mucosal barrier, and restore a healthy gut microbiome.
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