GUANGZHOU, China, July 5, 2024
/PRNewswire/ -- Zhiyi Biotech, a clinical-stage biotech leading in
discovery and development of LBPs (live biotherapeutic products),
today announced positive results from a Phase 1 clinical trial
in U.S. of SK10. SK10 is an innovative
heat-killed Bacteroides fragilis product for
Chemotherapy-induced Diarrhea (CID).
This was a randomized, double-blind, placebo-controlled,
sequential dose-escalation clinical study to evaluate the safety
and tolerability of SK10 in healthy adult subjects. A total of 24
healthy subjects were enrolled in the study. All dose groups of
SK10 were generally safe and well tolerated. All the TEAEs
(treatment-emergent adverse event) were mild in severity without
dose-dependent increase.
This promising result lays the
foundation for SK10 as a potential novel drug for CID patients.
About SK10:
SK10, the first Bacteroides fragilis-based LBP obtained
FDA IND approval, is also the first LBP of Next-generation
probiotics developed by Chinese biotech company that approved for
clinical trials by FDA. Studies have shown that SK10 can
ameliorate 5-FU induced injury via
mitochondrial apoptotic BCL2/BAX pathway, reduce inflammatory
cytokines, and enhance mucosal barrier function, thereby
effectively inhibiting the inflammatory response of intestinal
epithelial cells induced by chemotherapy and the associated
diarrhea symptoms.
Meanwhile, heat-killed Bacteroides fragilis
has better safety in cancer
patients and better commercialization performance.
About CID:
Cytotoxic drugs or targeted therapy can cause drug-associated
diarrhea. However, available drugs 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. Hence the need for
effective drugs is urgent.
About Zhiyi Bio:
Guangzhou Zhiyi Biotechnology Co., Ltd., as a clinical-stage
biotech leading in LBPs in China,
is committed to the research and development of LBPs, based on the
next generation probiotics (NGPs). It has built up a complete
technical and industrial platform, covering from the isolation and
identification of new functional strains to the development of
innovative products.
It's lead drug candidate SK08 is in Phase III clinical
trial for the treatment of IBS-D, and whose
clinical progress is ahead of other LBPs in China.
It's worth mentioning that Zhiyi has successfully completed a
total of $60 Million funding , with investors
including Qingkong SinoKing Capital, SDIC Venture Capital,
Guangdong Technology Financial Group, Shenzhen Capital Group,KIP
etc.
For more information, please visit
https://www.zypharm.com.cn
or contact: public@zypharm.com.cn
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SOURCE Zhiyi Biotech