News: The Phase I clinical trial of SK10 was approved by the US Ethics Committee
Release Time: 2023-07-31
On 27th July, 2023, the Phase I clinical trial of SK10, an innovative live biotherapeutic product (LBP) developed by Zhiyi Biotech, was approved by the US Ethics Committee. This is a randomized, double-blind, placebo-controlled, sequential dose-escalation Phase I clinical trial to evaluate the safety and tolerability of SK10 in healthy adult volunteers. Following the clinical kick-off meeting, the first enrollment will take place shortly at the Los Angeles Early Phase Clinical Unit.
About SK10:
SK10, the first Bacteroides fragilis-based LBP to receive FDA IND approval, is also the first LBP of Next-generation Probiotics in China that approved for clinical trials by FDA. This is the world’s first LBP indicated for Chemotherapy-induced Diarrhea (CID).
Inactivated Bacteroides fragilis was found to have significant therapeutic effects in CID models. Pre-clinical studies have shown that SK10 can reduce the toxicity of chemotherapeutic drugs towards intestinal epithelial cells, regulate the expression of apoptosis-related proteins, reduce inflammatory cytokines, and enhance mucosal barrier function, thereby effectively inhibiting the inflammatory response of intestinal epithelial cells induced by chemotherapy and the associated diarrheal symptoms. Meanwhile, this preparation has improved safety for cancer patients and better commercialization performance.
About Chemotherapy-induced Diarrhea (CID):
Cytotoxic drugs or targeted therapies can cause drug-associated diarrhea. Data shows that the overall incidence of diarrhea caused by 5-fluorouracil and irinotecan is of 50-80%, whilst it caused by EGFR inhibitors such as afatinib, neratinib and pyrotinib is of 75-90%. However, the drugs available for CID are limited. For example, loperamide, as a short-term symptomatic treatment, and octreotide, an intravenous/subcutaneous injection, serious adverse effects have been reported for both drugs. CID is a major factor leading to the adjustment, delay or even discontinuation of chemotherapy, with serious implications for patient survival and life quality. There is therefore an urgent clinical need.