Compositions and methods for treating non-alcoholic steatohepatitis
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Publication Number
US-11744808-B2
Publication Date
2023-09-05
Expiration Date
Abstract
Cepharanthine, Repirinast, Ifenoprodil Hemitartrate, Bromantane, Actarit, Lobenzarit, Irsogladine, Istradefylline, Trapadil, Bemithyl, and are used for treating or prophylaxis of lobular inflammation, non-alcoholic fatty liver disease or non-alcoholic steatohepatitis in a subject.
Core Innovation
The invention relates to methods for the treatment or prophylaxis of non-alcoholic fatty liver disease (NAFLD) in a subject by administering a therapeutically effective amount of repirinast. The described scope includes repurposed approved drugs and emphasizes NAFLD with focus on non-alcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma (NASH-HCC).
The problem addressed is NAFLD, including NASH and NASH-derived hepatocellular carcinoma, as reflected by the experimental evaluation of NASH and NASH-HCC in non-clinical models. The document describes readouts associated with hepatic injury and NAFLD/NASH pathology, including plasma ALT (alanine aminotransferase) and histological assessments of hepatic steatosis, lobular inflammation, and hepatocellular ballooning, as well as Sirius red fibrosis area.
The disclosure further includes a combination-therapy concept using the listed repurposed agents and other metabolic drugs, including cholesterol-lowering, diabetes, antihypertension, and Vitamin E. The non-clinical STAM/NASH-HCC and NASH induction models are reported with statistically significant improvements for certain agents, including reductions in fibrosis and hepatocellular ballooning for specified groups.
Claims Coverage
The document provides coverage centered on one independent claim with dependent claims that refine the treated condition and repirinast dosage. Across the claim set, there are inventive features corresponding to prophylaxis/treatment of NAFLD by repirinast administration, specifying repirinast dosage ranges, and limiting the indication to NAFLD subtypes, including NASH and NASH-derived hepatocellular carcinoma.
Repirinast administration for NAFLD prophylaxis or treatment
A method for the treatment or prophylaxis of non-alcoholic fatty liver disease in a subject, comprising administering a therapeutically effective amount of repirinast to the subject.
Repirinast dosage range for NAFLD
The method wherein the amount of repirinast administered to the subject is between 1 and 20 mg per kg.
Repirinast dosage range narrowed to 3 to 10 mg per kg
The method wherein the amount of repirinast is between 3 and 10 mg per kg.
Repirinast about 10 mg per kg
The method wherein the amount of repirinast is about 10 mg per kg.
NAFLD defined as non-alcoholic steatohepatitis
The method wherein the non-alcoholic fatty liver disease is non-alcoholic steatohepatitis.
NAFLD defined as non-alcoholic steatohepatitis-derived hepatocellular carcinoma
The method wherein the non-alcoholic fatty liver disease is non-alcoholic steatohepatitis-derived hepatocellular carcinoma.
Overall, the claim coverage is directed to repirinast as the therapeutic agent for NAFLD prophylaxis or treatment, with dependent limitations specifying repirinast dosage and restricting the NAFLD subtype to non-alcoholic steatohepatitis and non-alcoholic steatohepatitis-derived hepatocellular carcinoma.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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