Zhiyi Biotech Begins Phase 1 Trial of SK10 for Chemo-induced Diarrhea

28 August 2023 | Monday | News

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.

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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

Zhiyi Biotech Begins Phase 1 Trial of SK10 for Chemo-induced Diarrhea

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