Zhiyi Biotech announced that FDA has approved the Company’s Investigational New Drug (IND) application to develop SK10 (Inactivated Bacteroides fragilis) for the treatment of Chemotherapy-induced Diarrhea (CID) . The approval of this IND authorizes Zhiyi Biotech to conduct its Phase 1 clinical trial in the U.S.
It’s noteworthy that it is the world’s first IND application of live biotherapeutic products (LBPs) with CID as an indication. SK10, the first Bacteroides fragilis-based LBP that obtained FDA IND approval, is also the first LBP of Next-generation Probiotics in China that approved for clinical trial by FDA. Moreover, Zhiyi Biotech becomes the first company in China to advance inactivated preparation of LBP to the clinical stage. This achievement is an essential milestone for Zhiyi, signifying that Zhiyi has fully penetrated the technical and registration pathway of pre-clinical development of LBP to both FDA and NMPA.
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SK10, an inactivated Bacteroides fragilis-based LBP, has shown significant efficacy on CID models. Pre-clinical studies have indicated that SK10 can reduce the toxicity of chemotherapeutic drugs towards intestinal epithelial cells, regulate the expression of apoptosis-related proteins, reduce inflammatory cytokines, and enhance mucosal barrier function, thereby effectively inhibit the inflammatory response of intestinal epithelial cells induced by chemotherapy and associated diarrhea symptoms. Meanwhile, this preparation has better safety for cancer patients and is more convenient for commercialization.
Cytotoxic drugs or targeted therapy can cause drug-associated diarrhea. Data shows that the overall incidence of diarrhea caused by 5-fluorouracil and irinotecan is of 50-80%, whilst it caused by EGFR inhibitors such as afatinib, neratinib and pyrotinib is of 75-90%. However, available drugs for CID are limited. For example, loperamide, as a short-term symptomatic treatment, and octreotide, an intravenous/subcutaneous injection, serious adverse effects have been reported for both drugs. Hence the need for effective drugs is urgent.
Guangzhou Zhiyi Biotechnology Co., Ltd. , as clinical-stage biotech leading in LBPs in China , is committed to the research and development of LBPs, based on the next generation probiotics (NGPs). It has built up a complete technical and industrial platform, covering from the isolation and identification of new functional strains to the development of innovative products.