Chipscreen Biosciences Announces Successful Phase II Trial of Chiglitazar for NASH Treatment

19 March 2024 | Tuesday | News


Chipscreen Biosciences (688321.SH), a leading innovator in drug development, is pleased to announce the successful completion of its Phase II clinical trial (CGZ203 study) for chiglitazar, a promising monotherapy for non-alcoholic steatohepatitis (NASH), on February 22, 2024. This milestone marks a significant step forward in the battle against NASH, a condition with a growing prevalence and limited treatment options globally.
Image Source : Public Domain

Image Source : Public Domain

 

 

The CGZ203 study, a randomized, double-blind, placebo-controlled trial conducted across 24 national clinical sites, aimed to assess the safety and efficacy of chiglitazar in patients diagnosed with NASH. Under the leadership of Beijing Friendship Hospital affiliated to Capital Medical University, the trial met its primary efficacy endpoint, demonstrating significant reductions in liver fat content as evaluated by MRI-PDFF after 18 weeks of treatment.

Preliminary results reveal that both dosage groups of chiglitazar achieved dose-dependent improvements in liver fat content reduction, surpassing the placebo group's outcomes. Additionally, significant advancements were noted in secondary efficacy endpoints, including the proportion of patients experiencing over a 30% decrease in liver fat content and improvements in non-invasive indicators of hepatocyte damage, inflammation, and fibrosis.

Given the high incidence of non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD) in China, affecting over 25% of the general population, and the higher risk among individuals with metabolic syndrome, chiglitazar's development is timely and critical. Currently, the treatment landscape for NASH is limited, with only one thyroid receptor β (TRβ) agonist approved worldwide.

Chipscreen Biosciences is committed to advancing the clinical development of chiglitazar to address this unmet medical need. The company is currently undertaking further data analysis following the successful data cleaning and database locking of the CGZ203 study. With its promising preliminary results, chiglitazar stands as a beacon of hope for patients suffering from NASH, offering a potential new therapeutic option in the fight against this challenging liver disease.

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