Guangdong Zhongsheng Pharma Initiates Phase IIb Study for ZSP1601 in NASH

China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the first subject enrollment in a Phase IIb clinical study for its Category 1 drug ZSP1601, targeting non-alcoholic steatohepatitis (NASH). The study, set to be conducted across over 30 centers in China, will involve subjects stratified into randomized groups based on diabetes status and allocated to ZSP1601 50mg tablet group, ZSP1601 100mg tablet group, and placebo group in a ratio of 1:1:1. The trial is expected to run for 48 weeks.

Study Design and Primary Efficacy Endpoint
The primary efficacy endpoint of the study is to assess the proportion of subjects who show improvement in NASH with no deterioration of fibrosis in liver biopsy histology after 48 weeks of treatment, or who show an improvement of fibrosis by 1 point or more with no deterioration of NASH. This endpoint is crucial for evaluating the drug’s potential to address the underlying liver disease and fibrosis progression in NASH patients.

ZSP1601: A Potential First-in-Class NASH Therapy
ZSP1601, a potential first-in-class NASH therapy in China, has previously completed a Phase Ia study in healthy subjects and a Phase Ib/IIa study in NASH patients, both demonstrating good safety and tolerability. The Phase Ib/IIa study results indicated that the drug showed a favorable safety, tolerability, and pharmacokinetics profile in NASH patients. It positively changed alanine aminotransferase (ALT), aspartate aminotransferase (AST), fat content (PDFF), and other liver inflammation and injury observation indexes, with significant statistical differences from the placebo group.-Fineline Info & Tech

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