Zhiyi Biotech has announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of the company to develop SK10 (Inactivated Bacteroids fragilis) for the treatment of Chemotherapy-induced Diarrhea (CID). The approval of the IND application authorizes Zhiyi Biotech to conduct a Phase 1 clinical trial in the United States.
SK10 is the first LBP that received US FDA IND approval, and is also the first LBP of next-gen probiotics in China that has been is approved for clinical trial by the FDA. Zhiyi Biotech became the first company in China to an advance inactivated preparation of LBP to the clinical stage. This approval is an essential milestone for Zhiyi Biotech, signifying that the company has completely penetrated the registration and technical pathway of pre-clinical development to the US FDA.
SK10 has shown significant efficacy in CID models, and pre-clinical studies have indicated that SK10 can decrease the toxicity of chemotherapy drugs towards intestinal epithelial cells, by regulating the expression of proteins, enhancing mucosal barrier function, and decreasing inflammatory cytokines.
SK10 effectively inhibits the inflammatory response of intestinal epithelial cells that is induced by chemotherapy and diarrhea symptoms. Cytotoxic drugs can also cause drug-associated diarrhea.