GUANGZHOU, China I July 5, 2024 I Zhiyi Biotech, a clinical-stage biotech leading in discovery and development of LBPs (live biotherapeutic products), today announced positive results from a Phase 1 clinical trial in U.S. of SK10. SK10 is an innovative heat-killed Bacteroides fragilis product for Chemotherapy-induced Diarrhea (CID).

This was a randomized, double-blind, placebo-controlled, sequential dose-escalation clinical study to evaluate the safety and tolerability of SK10 in healthy adult subjects. A total of 24 healthy subjects were enrolled in the study. All dose groups of SK10 were generally safe and well tolerated. All the TEAEs (treatment-emergent adverse event) were mild in severity without dose-dependent increase.

This promising result lays the foundation for SK10 as a potential novel drug for CID patients.

About SK10:

SK10, the first Bacteroides fragilis-based 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. 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 diarrhea symptoms.

Meanwhile, heat-killed Bacteroides fragilis has better safety in cancer patients and better commercialization performance.

About CID:

Cytotoxic drugs or targeted therapy can cause drug-associated diarrhea. 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.

It’s lead drug candidate SK08 is in Phase III clinical trial for the treatment of IBS-D, and whose clinical progress is ahead of other LBPs in China.

It’s worth mentioning that Zhiyi has successfully completed a total of $60 Million funding , with investors including Qingkong SinoKing Capital, SDIC Venture Capital, Guangdong Technology Financial Group, Shenzhen Capital Group,KIP etc.

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SOURCE: Zhiyi Biotech