On July 5, 2024 Zhiyi Biotech, a clinical-stage biotech leading in discovery and development of LBPs (live biotherapeutic products), reported positive results from a Phase 1 clinical trial in U.S. of SK10 (Press release, Guangzhou Zhiyi Biotech, JUL 5, 2024, View Source [SID1234644693]). SK10 is an innovative heat-killed Bacteroides fragilis product for Chemotherapy-induced Diarrhea (CID).

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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.