2024-03-15 06:00:58
According to a study conducted in 2019, nearly 17% of French people are affected by fatty liver disease, sometimes without even knowing it. The people most affected by this disease would be people suffering from obesity and/or type 2 diabetes. Currently, no treatment is available for fatty liver disease, although it constitutes a risk factor for liver cancer. . Resmeritom is a drug candidate, the latest clinical data of which shows promise.
Hepatic steatosis, from NASH to MASH
Hepatic steatosis correspond to excessive accumulation of fats in liver cells, hepatocytes. Initially, specialists described a disease, NASH, for non-alcoholic fatty liver disease, to differentiate between hepatic steatosis linked or not to chronic alcohol consumption. More recently, specialists have introduced another name, MASH for hepatic steatosis linked to metabolic dysfunction. MASH, very difficult to distinguish histologically from alcohol-related liver damage, is characterized by two mechanisms:
Lipotoxicity, that is to say toxicity of lipids stored in the liver; Inflammatory lesions of hepatocytes.
MASH is today considered to be a major risk factor for hepatocellular carcinoma, liver cancer. Unfortunately, the course of MASH is often insidious, with patients experiencing no hepatic symptoms for a long time. Faced with this metabolic pathology, undoubtedly linked to insulin resistance (tissue resistance to the action of insulin), there is currently no treatment. Therapies are being developed, including resmeritom.
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Resmeritom, soon the first treatment for fatty liver?
Resmeritom is the lead drug candidate in the race to become the first treatment for MASH. In a phase 3 clinical trial, the results of which were published in early 2024 in the scientific journal The New England Journal of Medicine, promising results were obtained. Resmeritom acts selectively on a thyroid hormone receptor, modifying their action on the liver. Thyroid hormones perform many physiological and metabolic roles, including reducing lipids in the bloodstream and reducing liver fat by breaking down fatty acids.
In the phase 3 clinical trial, 966 patients with MASH confirmed by liver biopsy, with different stages of liver fibrosis, were randomly divided into three groups:
322 patients received 80 mg of resmeritom per day; 323 patients received 100 mg of resmeritom daily; 321 patients received a placebo.
To know ! Liver fibrosis is excessive scarring of liver tissue following injury. It manifests itself by the accumulation of connective tissue in the liver, rendering the liver tissues nonfunctional.
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Promising effectiveness and acceptable tolerance
Resmeritom showed in this trial an action once morest hepatic fibrosis and an effectiveness in reducing the accumulation of fats in the liver. An improvement in MASH without worsening of liver fibrosis was observed in more than one in 4 patients treated with resmeritom dosed at 80 mg and in almost one in three patients with resmeritom dosed at 100 mg. In patients treated with placebo, only one in 10 patients saw their MASH stabilize. Resmeritom even helped reduce liver fibrosis for approximately 1 in 4 patients in the two groups treated with resmeritom. Treatment with resmeritom also helped improve LDL cholesterol levels, the “bad” cholesterol.
Side effects were noted in a similar proportion of patients in the three trial groups. The most common side effects with resmeritom were diarrhea and nausea. The American Medicines Agency is currently examining data from clinical trials, in order to position itself for the possible marketing of resmeritom in the coming months. It would thus become the first drug once morest MASH, thus contributing to the active fight once morest this metabolic disease, but also once morest liver cancer.
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Estelle B., Doctor of Pharmacy
– Treatment of MASH: encouraging results for resmetirom. pnmvh.org. Accessed March 11, 2024.
– A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis.www.nejm.org. Consulté le && mars 2024.
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