Chipscreen says MASH candidate chiglitazar succeeds in Phase II
18 Mar 2024
Drug ApprovalPhase 2Clinical Result
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 inhibitorFASN 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.
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