The asset is said to effectively curb the inflammatory response of intestinal epithelial cells caused by chemotherapy and the resulting diarrhoea symptoms. Credit: Vita Sun / Shutterstock.

Guangzhou Zhiyi Biotechnology (Zhiyi Biotech) has reported positive data from the Phase I clinical trial in the US assessing SK10, a heat-killed Bacteroides fragilis, intended for the treatment of chemotherapy-induced diarrhoea (CID).

The double-blind, randomised, placebo-controlled, sequential dose-escalation trial was designed to assess the safety and tolerability of SK10 in healthy adult subjects.

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In August 2023, the company dosed the first three subjects in the trial with a total of 24 subjects.

The results indicated that all dose groups of SK10 were generally safe and well-tolerated.

Importantly, all treatment-emergent adverse events (TEAEs) were mild and did not increase with the dose.

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SK10 is said to be the first Bacteroides fragilis-based live biotherapeutic product (LBP) to receive investigational new drug application (IND) approval from the US Food and Drug Administration (FDA).

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Research has demonstrated that it can mitigate 5-FU-induced injury through the mitochondrial apoptotic BCL2/BAX pathway, decrease inflammatory cytokines, and bolster mucosal barrier function.

Consequently, the therapy effectively curbs the inflammatory response of intestinal epithelial cells caused by chemotherapy and the resulting diarrhoea symptoms.

The safety profile of heat-killed Bacteroides fragilis is notably better in cancer patients, and it also presents improved commercialisation prospects, the company noted.

CID is often a side effect of cytotoxic drugs or targeted therapy, with limited treatment options available presently.

The company focuses on the research and development of LBPs based on next-generation probiotics (NGPs). Its lead drug candidate, SK08, is currently in a Phase III clinical trial for the treatment of IBS-D.

Zhiyi Biotech previously secured $60m in a funding round with investments from Qingkong SinoKing Capital and SDIC Venture Capital among others.