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.
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