Zhiyi Biotech announces positive Phase I results for SK10 in CID treatment

Guangzhou Zhiyi Biotechnology (Zhiyi Biotech) has released promising findings from its Phase I clinical trial conducted in the US on SK10, a heat-killed form of Bacteroides fragilis aimed at addressing chemotherapy-induced diarrhoea (CID). The trial, employing a double-blind, randomised, placebo-controlled, sequential dose-escalation design, assessed SK10's safety and tolerance in healthy adults, with the first three subjects dosed in August 2023 out of a total of 24 participants.

Results indicated that all doses of SK10 were generally safe and well-tolerated, with all treatment-related adverse events being mild and not escalating with dosage. SK10 marks the first Bacteroides fragilis-based live biotherapeutic product (LBP) to receive investigational new drug application (IND) approval from the US FDA. Studies have shown its potential to mitigate chemotherapy-induced injury via the mitochondrial apoptotic BCL2/BAX pathway, reduce inflammatory cytokines, and enhance mucosal barrier function, effectively mitigating CID symptoms in cancer patients.