Zhiyi Biotech Completes Phase I Trial of SK10 for Chemotherapy-induced Diarrhea

Zhiyi Biotech, a prominent clinical-stage biotechnology company based in Guangzhou, China, has announced encouraging results from a Phase 1 clinical trial conducted in the United States for SK10, a groundbreaking heat-killed Bacteroides fragilis product designed to treat Chemotherapy-induced Diarrhea (CID).

The clinical trial was a randomized, double-blind, placebo-controlled, sequential dose-escalation study aimed at assessing the safety and tolerability of SK10 in healthy adults. The study enrolled 24 healthy participants and demonstrated that all doses of SK10 were generally safe and well-tolerated. All treatment-emergent adverse events (TEAEs) were mild and did not show a dose-dependent increase.

These promising findings pave the way for SK10 to become a potential novel treatment for patients suffering from CID. The significance of SK10 is further underscored by its status as the first Bacteroides fragilis-based live biotherapeutic product (LBP) to receive FDA Investigational New Drug (IND) approval. It is also notable for being the first next-generation probiotic developed by a Chinese biotechnology company to be approved for clinical trials by the FDA.

Research has indicated that SK10 can mitigate 5-fluorouracil (5-FU)-induced injury through the mitochondrial apoptotic BCL2/BAX pathway, decrease inflammatory cytokines, and improve mucosal barrier function. This effectively reduces the inflammatory response in intestinal epithelial cells caused by chemotherapy and alleviates the associated diarrhea symptoms. Moreover, the use of heat-killed Bacteroides fragilis presents a safer option for cancer patients and shows better potential for commercialization.

CID, a common side effect of cytotoxic drugs or targeted therapies, presents a significant challenge in cancer treatment. Current treatment options like loperamide and octreotide have limited efficacy and can cause serious adverse effects. This highlights the urgent need for more effective treatments, making the development of SK10 particularly timely and important.

Zhiyi Biotech, the company behind SK10, is a leading player in the field of LBPs in China. The company is dedicated to the research and development of next-generation probiotics (NGPs) and has established a comprehensive technical and industrial platform. This platform encompasses the isolation and identification of new functional strains as well as the development of innovative products.

In addition to SK10, Zhiyi Biotech's flagship drug candidate, SK08, is currently in Phase III clinical trials for the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D). The progress of SK08 in clinical trials is ahead of other LBPs being developed in China.

Zhiyi Biotech has also successfully secured a total of $60 million in funding from various investors, including Qingkong SinoKing Capital, SDIC Venture Capital, Guangdong Technology Financial Group, Shenzhen Capital Group, and KIP. This financial backing underscores the confidence that investors have in the company's innovative approach and potential for success in the biotechnology sector.