Policy & Regulation
Zhiyi Biotech announces positive results from SK10 US phase one clinical trial
8 July 2024 -

Zhiyi Biotech, a clinical-stage biotech involved in the discovery and development of LBPs (live biotherapeutic products), announced on Friday positive results from a Phase 1 clinical trial in the US of SK10.

SK10 is an innovative heat-killed Bacteroides fragilis product for Chemotherapy-induced Diarrhoea (CID).

The trial, a randomised, double-blind, placebo-controlled, sequential dose-escalation clinical study, was to assess the safety and tolerability of SK10 in healthy adult patients. The company enrolled a total of 24 healthy subjects in the study. The SK10 dose groups were generally safe and well tolerated.

The study revealed that all the TEAEs (treatment-emergent adverse event) were mild in severity without dose-dependent increase. The company says that the promising outcome lays the foundation for SK10 as a potential novel drug for CID patients.