Chiglitazar Sodium

SHENZHEN, China, March 18, 2024 /PRNewswire/ -- On March 18 2024, Shenzhen chipscreen biosciences Co., Ltd. (hereinafter referred to as "chipscreen biosciences", stock code: 688321. SH) announced that the Phase II clinical trial (CGZ203 study) of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) was successfully completed with data cleaning and database locking on February 22, 2024. The primary efficacy endpoint of the trial has been achieved, and further data analysis is currently underway. The incidence of non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD) in the general population of China exceeds 25%, of which about 25% will progress to NASH, and this proportion is even higher in patients with metabolic syndrome. Currently, there is only one thyroid receptor β (TRβ) agonist approved worldwide. The CGZ203 study is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial aimed to evaluate the safety and preliminary efficacy of chiglitazar monotherapy in diagnosed NASH patients. The CGZ203 study was led by Beijing Friendship Hospital affiliated to Capital Medical University and conducted in 24 clinical sites nationwide. Preliminary results showed that both dose groups of chiglitazar produced significant and dose-dependent reductions at the primary efficacy endpoint (the proportion of changes from baseline in liver fat content evaluated by MRI-PDFF after 18 weeks of treatment), compared to placebo control group. In terms of secondary efficacy endpoints such as the proportion of patients with an over 30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis and so on, both dose groups of chiglitazar also showed significant or dose-dependent trend of improvements. The overall safety is good. The detailed research results will be presented on an upcoming scientific conference or in research article. About Chiglitazar: Chiglitazar (Carfloglitazar) is a novel peroxisome proliferator activation related receptor (PPAR) pan-agonist, independently discovered and developed by Shenzhen chipscreen biosciences with global patent protection. It was firstly approved in China in October 2021, for clinical treatment of type 2 diabetes patients who cannot be effectively controlled by exercise and diet control. It is also the first approved PPAR pan-agonist in the world. Chiglitazar has already completed a phase III trial of combination with metformin to treat type 2 diabetes patients (RECAM study) and the current phase II trial in NASH patients (CGZ203) in China. About CGZ203: CGZ203 is an exploratory phase II trial aimed at treating NASH patients. It was designed as a randomized, double-blind, placebo-controlled multicenter clinical trial. The clinically diagnosed NASH patients were randomly enrolled in a ratio of 2:2:1 to receive oral administration of chiglitazar 48 mg, 64 mg, and placebo once a day respectively, with a treatment period of 18 weeks. The primary efficacy endpoint is the percentage of changes from baseline in liver fat content (LFC) evaluated by magnetic resonance proton density fat fraction (MRI-PDFF) after 18 weeks of treatment. Secondary endpoints include the absolute value of LFC changes, the proportion of people with a decrease of more than 30% in LFC, changes in other non-invasive indicators of liver cell damage, inflammation, and fibrosis, and the patient safety during the trial period. About Chipscreen: Shenzhen Chipscreen biosciences is a modern biopharmaceutical enterprise founded by a senior overseas Returnees team in 2001. The company specializes in the discovery and development of original new molecular entity drugs, focus on five major disease fields of cancer, metabolic diseases, autoimmune diseases, central nervous system diseases. With the independently created "integrated drug discovery and early evaluation platform based on chemical genomics", chipscreen has developed multiple original new drugs including two marketed products Chidamide (Tucidinostat) and Chiglitazar (Carfloglitazar), several clinical stage drug candidates Chiauranib (phase III), CS12192 (phase I), CS23546 (phase I), and CS32582 (Phase I). Till now, chipscreen has established a global industrial layout consisting of its headquarters, R&D center, a wholly-owned subsidiary of GMP production base (Shenzhen chipscreen Pharmaceutical Co., Ltd.) in Shenzhen, a wholly-owned subsidiary of its Chengdu regional headquarters/R&D center/innovative drug production base (Chengdu chipscreen Pharmaceutical Co., Ltd.) in Chengdu, Beijing branch (clinical research center), Shanghai branch (commercial center), and chipscreen Biosciences (USA) Co., Ltd. Chipscreen is one of the first batch of national "innovative drug incubation bases" and a national high-tech enterprise, independently undertakes dozens of national "863", "10th/11th/12th/13th five year plan of major scientific and technological special projects", and "major new drug creation" projects. A total of over 600 domestic and foreign invention patents have been applied, and over 160 have been authorized. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Shenzhen Chipscreen Biosciences Co. is the latest company to report positive data for a metabolic dysfunction-associated steatohepatitis (MASH) drug candidate. On Monday, the Chinese biotech said its PPAR pan-agonist chiglitazar cleared a key hurdle, meeting the primary efficacy endpoint of a Phase II study.The trial win comes on the heels of the FDA's approval last week of Madrigal Pharmaceuticals' THR-β selective agonist Rezdiffra (resmetirom), the first drug waved through by US regulators to treat the liver disease. Cleared via the FDA's accelerated pathway, Rezdiffra is indicated for adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis consistent with stages F2 to F3 fibrosis. The drug hits the market next month at a US list price of $47,400 per year.Chiglitazar, also known as carfloglitazar, has been approved in China since 2021 under the brand name Bilessglu to treat type 2 diabetes.The current trial, dubbed CGZ203, tested two doses of chiglitazar monotherapy or placebo given once daily for 18 weeks to patients diagnosed with MASH. Chipscreen said the primary endpoint was met at both dose levels, producing "significant and dose-dependent reductions" in liver fat content compared to placebo after 18 weeks, based on MRI-proton density fat fraction (MRI-PDFF).Both dose groups also showed "significant or dose-dependent trend of improvements" on secondary measures such as the proportion of patients achieving a >30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis, the company said. Chipscreen said "overall safety is good," and that further data analyses are underway.Other MASH drug hopefuls with recent positive readouts include Akero Therapeutics' efruxifermin, engineered to mimic the FGF21 hepatic hormone; Ionis Pharmaceuticals' antisense inhibitor ION224; Sagimet Biosciences' FASN inhibitor denifanstat; the dual GLP-1 and glucagon agonist survodutide being co-developed by Boehringer Ingelheim and Zealand Pharma; as well as Viking Therapeutics' VK2809, which like Rezdiffra also targets thyroid hormone receptor beta.