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SK08
- Development stage
- Phase 3
- Lead developer
- Zhiyi Pharmaceutics
- Modality
- Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
- Administration
- Oral
01
Overview
SK08 is a live biotherapeutic product (LBP) consisting of the bacterial strain Bacteroides fragilis, under development by Guangzhou Zhiyi Biotechnology Co., Ltd. [2]. As the company's lead candidate, SK08 is being investigated for several indications. It is in Phase 3 clinical trials for irritable bowel syndrome with diarrhea (IBS-D) and is also being studied in a Phase 2 trial for mild to moderate ulcerative colitis. [1, 3, 4] Additionally, SK08 is being explored for its potential to enhance anti-tumor immunity in combination with PD-1 inhibitors for advanced solid tumors in a Phase 1b/2 trial.
- Brand names
- Live SK08
- Other names
- Live SK08 Powder (Bacteroidetes fragilis)SK08 Live Bacteria PowderSK-08 Live Bacteria PowderSK 08 Live Bacteria Powder
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