GUANGZHOU, China, Aug. 25, 2023 /PRNewswire/ — On August 23rd 2023, Zhiyi Biotech announced that the first three subjects have been dosed in the U.S. Phase 1 clinical trial of SK10, an innovative heat-killed Bacteroides fragilis product developed by Zhiyi Biotech for Chemotherapy-induced Diarrhea (CID). The U.S. Phase 1 trial is a First-in-Human study of SK10, designed as a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the safety and tolerability of SK10 in healthy adult subjects. The study is anticipated to enroll 24 healthy subjects to sequentially test three ascending doses of orally administered SK10.
SK10, the first Bacteroides fragilis-based live biotherapeutic product (LBP) obtained FDA IND approval, is also the first LBP of Next-generation probiotics developed by Chinese biotech company that approved for clinical trials by FDA. It was the world’s first application of LBPs for Chemotherapy-induced Diarrhea (CID).
With metagenomic sequencing, Bacteroides fragilis was identified as the key microbiota which contributed to microbial alteration after chemotherapy exposure. Studies have shown that SK10 can ameliorate 5-FU induced injury via mitochondrial apoptotic BCL2/BAX pathway, reduce inflammatory cytokines, and enhance mucosal barrier function, thereby effectively inhibiting the inflammatory response of intestinal epithelial cells induced by chemotherapy and the associated diarrheal symptoms.
Meanwhile, heat-killed Bacteroides fragilis had better safety in cancer patients and better commercialization performance.
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.
About Zhiyi Bio:
Guangzhou Zhiyi Biotechnology Co., Ltd., as a 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.