Guangzhou-based Zhiyi Biotechnology has announced receiving clearance from the US FDA for a clinical study of its SK10 (inactivated Bacteroides fragilis) in chemotherapy-induced diarrhea (CID). This marks a significant milestone in the development of live biotherapeutic products (LBPs) for addressing unmet medical needs.
First-in-Class IND Approval
Notably, this is the world’s first Investigational New Drug (IND) application for an LBP targeting CID. SK10 is the first Bacteroides fragilis-based LBP to obtain FDA IND approval and represents the first next-generation probiotic LBP in China to be approved for clinical trial by the FDA. Zhiyi Biotechnology thus becomes the first company in China (and the world’s third) to advance an inactivated LBP preparation to the clinical stage.
Unmet Need in Chemotherapy-Induced Diarrhea
Cytotoxic drugs and targeted therapies can cause drug-associated diarrhea, with significant incidence rates. Data shows 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 pyrotinib is 75-90%. Despite the high incidence, available treatments for CID are limited. Current options include loperamide, a short-term symptomatic treatment, and octreotide, an intravenous/subcutaneous injection, both of which have reported serious adverse effects. The need for more effective and safer treatments is therefore urgent.
Future Outlook
The FDA clearance for Zhiyi Biotechnology’s SK10 underscores the potential of LBPs in addressing chemotherapy-induced diarrhea. This development highlights the company’s leadership in advancing innovative biotherapeutic solutions for patients with significant unmet medical needs.-Fineline Info & Tech
