Zhiyi Biotech has announced the initiation of the U.S. Phase 1 clinical trial for their innovative product SK10, which is aimed at addressing Chemotherapy-induced Diarrhea (CID). The trial marks a significant milestone as the first three subjects have been successfully dosed. SK10 is a heat-killed Bacteroides fragilis product developed by Zhiyi Biotech.

The U.S. Phase 1 trial for SK10 is designed as a First-in-Human study, employing a randomized, double-blind, placebo-controlled, sequential dose-escalation approach. The primary objective of the trial is to assess the safety and tolerability of SK10 in healthy adult subjects. It is expected to enroll a total of 24 healthy individuals, who will be sequentially administered three ascending doses of SK10 orally.

SK10 is notable for being the first Bacteroides fragilis-based live biotherapeutic product (LBP) to receive FDA Investigational New Drug (IND) approval. Developed by the Chinese biotech company Zhiyi Biotech, SK10 is categorized as a Next-generation probiotic and is the first LBP of its kind approved by the FDA for clinical trials. This innovation focuses on addressing Chemotherapy-induced Diarrhea (CID), which is a significant concern in cancer treatment.

Research using metagenomic sequencing identified Bacteroides fragilis as a key microbiota contributor to the alterations in microbial composition following exposure to chemotherapy. Studies have indicated that SK10 can mitigate the damage induced by the chemotherapy agent 5-fluorouracil (5-FU) by modulating the mitochondrial apoptotic BCL2/BAX pathway, reducing inflammatory cytokines, and enhancing mucosal barrier function. This leads to the effective suppression of the inflammatory response in intestinal epithelial cells induced by chemotherapy, ultimately alleviating associated diarrheal symptoms.

Furthermore, SK10's status as a heat-killed Bacteroides fragilis product provides advantages in terms of safety for cancer patients and improved commercialization prospects. This development is a significant step towards providing an innovative solution for Chemotherapy-induced Diarrhea (CID) and enhancing the quality of life for cancer patients undergoing treatment.