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Non-alcoholic steatohepatitis (NASH) is an aggressive form of non-alcoholic fatty liver disease (NAFLD). It is indicated by excessive accumulation of fat in the liver, inflammation, cell injury and fibrosis. Non-alcoholic fatty liver disease (NAFLD) is a significant cause of liver disease across the world. The global prevalence of NAFLD is estimated to be over 25% with maximum prevalence in the Middle East and South America, and lowermost in Africa.
In 2021, advances in non-alcoholic fatty liver disease were revealed at the International Liver Congress in Geneva, Switzerland. A key development discussed at the meeting was a study that showed noninvasively identified non-alcoholic steatohepatitis (NASH) patients treated with 100 mg per day of resmetirom for up to fifty-two weeks exhibited rapid and sustained reduction in fibrosis stage, hepatic fat, LDL and atherogenic lipids, inflammatory biomarkers and liver enzymes. Such developments are expected to boost the global non-alcoholic steatohepatitis (NASH) treatment market.
In 2021, Akero announced positive histological improvements in cirrhotic NASH (F4) patients after sixteen weeks in Extension Cohort C. 33% of patients treated with efruxifermin (EFX) (4 of 12) showed improvement by one fibrosis stage without deterioration of NASH. 25% of EFX patients (3 of 12) exhibited NASH resolution. Rapid fibrosis improvement in cirrhotic patients was observed after only 16 weeks of EFX treatment, the highest rate reported publicly to date, suggested direct anti-fibrotic effects.
In 2019, Gilead presented new data on non-alcoholic Steatohepatitis (NASH) at the International Liver Congress™ 2019 in Vienna. The data supported Gilead’s efforts to develop combination therapies to target different aspects of NASH, assess the utility of non-invasive tests for the recognition of patients living with the disease and advance overall understanding of the complexities and burden of NASH. Such developments are expected to boost the global non-alcoholic steatohepatitis (NASH) treatment market.
In 2020, LG Chem announced that it had received approval for NASH treatment for Clinical Phase 1 Trial by the USA FDA. The approval was to conduct clinical trials for candidate material with mechanism for suppressing liver inflammations based on outstanding pre-clinical results. LG Chem would begin clinical development for new NASH drugs in the USA.
In 2018, Novartis announced that it had entered into a clinical development agreement with Pfizer which would include a study combining tropifexor and one or more Pfizer compounds for the treatment of NASH, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, and a Ketohexokinase (KHK) Inhibitor (PF-06835919).
In 2021, Boehringer Ingelheim and Zealand Pharma A/S announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH).
In 2022, Intercept Pharmaceuticals, Inc. announced positive topline results from a new interim analysis of its ongoing pivotal Phase 3 REGENERATE trial of OCA in patients with liver fibrosis due to non-alcoholic steatohepatitis (NASH).
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