Zhiyi Biotech, a pioneering clinical-stage biotech specializing in live biotherapeutic products (LBPs), has achieved significant milestones with its latest clinical trial results for SK10. The Phase I study, conducted in the United States, has demonstrated promising outcomes in the treatment of chemotherapy-induced diarrhea (CID) using SK10, an innovative heat-killed Bacteroides fragilis product.
The randomized, double-blind, placebo-controlled trial involved 24 healthy adult subjects and focused on evaluating the safety and tolerability of SK10. Encouragingly, all dose groups exhibited general safety and were well tolerated, with mild treatment-emergent adverse events reported. This positive safety profile lays a robust foundation for SK10’s advancement as a potential breakthrough therapy for CID patients, addressing a critical unmet medical need.
Editorial Opinion:
Zhiyi Biotech’s successful Phase I trial marks a significant advancement in the field of live biotherapeutic products, particularly in combating chemotherapy-induced diarrhea. The innovative use of heat-killed Bacteroides fragilis, coupled with FDA IND approval, underscores Zhiyi’s pioneering role in developing next-generation probiotics. SK10’s ability to mitigate chemotherapy-induced intestinal damage through targeted mechanisms such as the mitochondrial apoptotic pathway and enhancement of mucosal barrier function highlights its potential to revolutionize CID treatment.
Moreover, Zhiyi Biotech’s comprehensive approach—from strain isolation and identification to product development—reflects its commitment to scientific excellence and innovation in biotechnology. With substantial financial backing and strategic partnerships with leading investors, including Qingkong SinoKing Capital and SDIC Venture Capital, Zhiyi is well-positioned to drive forward its pipeline of LBPs, including the promising Phase III candidate SK08 for IBS-D treatment.
As Zhiyi Biotech continues to expand its clinical footprint and advance its novel therapies, it stands poised to make profound contributions to global healthcare, particularly in gastrointestinal disorders and beyond.
If you need further assistance or have any corrections, please reach out to editor@thetimesmag.com.
