Chiglitazar Monotherapy Shows Promise in Phase II NASH Trial

On March 18, 2024, Shenzhen Chipscreen Biosciences Co., Ltd., a leading biopharmaceutical company, announced the successful completion of the Phase II clinical trial (CGZ203 study) for Chiglitazar monotherapy in treating non-alcoholic steatohepatitis (NASH). The study, which concluded with data cleaning and database locking on February 22, 2024, has met its primary efficacy endpoint, and further analysis is in progress.

In China, over 25% of the population is affected by non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD), with a quarter of these cases expected to develop into NASH. This figure is even more significant among individuals with metabolic syndrome. Currently, there is only one approved thyroid receptor β (TRβ) agonist globally.

The CGZ203 study, conducted under the leadership of Beijing Friendship Hospital and spanning 24 clinical sites, was a randomized, double-blind, placebo-controlled, multicenter Phase II trial. It aimed to assess the safety and preliminary efficacy of Chiglitazar monotherapy in NASH patients. Early findings indicate that Chiglitazar, in both tested dosages, significantly reduced liver fat content, as measured by MRI-PDFF, after 18 weeks of treatment, outperforming the placebo group. Additionally, secondary endpoints, including a significant decrease in liver fat content and improvements in non-invasive indicators of liver health, demonstrated promising results. The drug showed a favorable safety profile.

Chiglitazar, also known as Carfloglitazar, is a novel PPAR pan-agonist developed by Chipscreen Biosciences and protected by global patents. It was first approved in China in October 2021 for treating type 2 diabetes patients with inadequate control through diet and exercise, marking it as the world's first approved PPAR pan-agonist. Chiglitazar has also completed a Phase III trial in combination with metformin for type 2 diabetes treatment.

The CGZ203 trial was designed to explore the effects of Chiglitazar on NASH patients, with participants receiving either 48 mg or 64 mg of the drug or a placebo daily for 18 weeks. The primary goal was to measure changes in liver fat content, with secondary objectives assessing liver health indicators and patient safety.

Shenzhen Chipscreen Biosciences, established in 2001 by a team of experienced overseas returnees, is dedicated to the discovery and development of innovative drugs, focusing on major disease areas such as cancer, metabolic diseases, autoimmune diseases, and central nervous system disorders. The company has an "integrated drug discovery and early evaluation platform based on chemical genomics," which has led to the development of several original drugs, including Chidamide and Chiglitazar, as well as clinical-stage candidates.

Chipscreen Biosciences has a global presence with its headquarters, R&D centers, production bases, and branches in key cities. The company is recognized as a national high-tech enterprise and has been involved in numerous national projects, with over 600 patents filed and more than 160 authorized.