– Zhiyi Biotech announced the first subject dosed in the US Phase 1 clinical trial of SK10, under development for the treatment of chemotherapy-induced diarrhea
GUANGZHOU, China, Aug. 25, 2023/PRNewswire/ — On Aug. 23, 2023, Zhiyi Biotech announced that the first three subjects received doses in the US Phase 1 clinical trial of SK10, an innovative product of Heat-killed Bacteroides fragilis developed by Zhiyi Biotech for chemotherapy-induced diarrhea (CID). The US Phase 1 trial is the first human study of SK10, designed as a randomized, double-blind, placebo-controlled, sequential dose-escalation study to assess the safety and tolerability of SK10 in healthy adult subjects. The study is anticipated to enroll 24 healthy subjects to sequentially test three ascending doses of orally administered SK10.
About SK10:
The first Bacteroides fragilis-based live biotherapeutic (LBP) product to gain FDA IND approval, SK10 is also the first next-generation probiotic LBP developed by a Chinese biotech company to be approved for clinical trials by the FDA. It was the world’s first low back pain app for chemotherapy-induced diarrhea (CID).
With metagenomic sequencing, Bacteroides fragilis was identified as the key microbiota contributing to microbial disruption after chemotherapy exposure. Studies have shown that SK10 can ameliorate 5-FU-induced injury through the mitochondrial BCL2/BAX apoptotic pathway, reduce inflammatory cytokines and improve mucosal barrier function, thereby effectively inhibiting the inflammatory response of intestinal epithelial cells. induced by chemotherapy and associated diarrheal symptoms.
Meanwhile, heat-killed Bacteroides fragilis had higher safety in cancer patients and better commercialization performance.
About C.I.D.:
Cytotoxic drugs or targeted therapy can cause drug-associated diarrhea. Data show that the overall incidence of diarrhea caused by 5-fluorouracil and irinotecan is 50-80%, while that caused by EGFR inhibitors such as afatinib, neratinib and pirotinib is 75-90%. However, the medications available for DIC are limited. For example, serious adverse effects have been reported for both loperamide drugs, as short-term symptomatic treatment, and octreotide, an intravenous/subcutaneous injection. Hence the need for effective drugs is urgent.
About Zhiyi Bio:
Guangzhou Zhiyi Biotechnology Co., Ltd., as China’s leading LBP clinical stage biotech, is committed to the research and development of LBP, based on Next Generation Probiotics (NGP). It has created a complete technical and industrial platform, ranging from the isolation and identification of new functional strains to the development of innovative products.
For more information, please visit https://www.zypharm.com.cn or contact: public@zypharm.com.cn
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