Methods for treating liver disease
AssigneeCymaBay Therapeutics, Inc.
InventorsSusheela Y. Carroll, Yun-Jung Choi, Daria B. Crittenden, Robert L. Martin, Charles A. McWherter, Sarah C. Proehl, Alexandra V. Steinberg
Life of this patent
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Abstract
The present disclosure relates generally to treating liver diseases, such as primary biliary cholangitis (PBC), comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof
Claims120
A method of treating primary biliary cholangitis (PBC) in a patient in need thereof, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein administration of seladelpar or a pharmaceutically acceptable salt thereof results in one or more of:
- (a) an improvement in cholestasis;
- (b) an improvement in liver injury;
- and (c) an improvement or prevention of pruritus.
A method of treating primary biliary cholangitis (PBC) in a patient in need thereof, the method comprising administering seladelpar or a pharmaceutically acceptable salt thereof to the patient in an amount equivalent to 5 mg/day or 10 mg/day of seladelpar, wherein administration of seladelpar or a pharmaceutically acceptable salt thereof results in one or more of:
- (a) an improvement in cholestasis;
- (b) an improvement in liver injury;
- and (c) an improvement or prevention of pruritus.
A method of treating a liver disease in a patient in need thereof, comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein the patient does not have decompensated cirrhosis.
A method of administering seladelpar therapy in a subject in need thereof, comprising administration of a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to a patient, wherein the patient does not have decompensated cirrhosis.
A method of treating a liver disease in a patient in need thereof, comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient and monitoring or testing the patient for signs of drug-induced liver injury or abnormalities.
A method of administering seladelpar therapy in a subject in need thereof, comprising administration of a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to a patient and monitoring or testing the patient for signs of drug-induced liver injury or abnormalities.
A method of treating a liver disease in a patient in need thereof, comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient and testing and optionally treating the patient for bone density and/or bone health.
A method of providing seladelpar therapy to a patient in need thereof, comprising administration of a therapeutically effective amount of seladelpar, further comprising monitoring and optionally treating the patient for bone density and/or bone health.
A method of treating a liver disease in a patient in need thereof, comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein the patient does not have complete biliary obstruction.
A method of providing seladelpar therapy to a patient in need thereof, comprising administering a therapeutically effective amount of seladelpar or a salt thereof, wherein the patient is not identified to have complete biliary obstruction.
A method of treating a liver disease in a patient in need thereof, wherein the patient has renal impairment, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein the amount of seladelpar is 5 mg/day or 10 mg/day.
A method of administering seladelpar therapy in a patient in need thereof, wherein the patient has renal impairment, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof, wherein the amount of seladelpar is 5 mg/day or 10 mg/day.
A pharmaceutical composition comprising:
- seladelpar or a pharmaceutically acceptable salt thereof in an amount equivalent to 5 mg/day or 10 mg of seladelpar, butylated hydroxytoluene, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose.
A method of increasing serum level of one or more metabolism markers in a patient in need thereof, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein said one or more metabolism markers are selected from the group consisting of carnitine, acetylcarnitine, acylcarnitines, N,N,N-trimethyl-5-aminovalerate, and branched-chain amino acid catabolites.
A method of decreasing serum level of one or more metabolism markers in a patient in need thereof, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein said one or more metabolism markers are selected from dicarboxylates, saturated and unsaturated fatty acids, and lipid-derived inflammatory mediators.
A method of decreasing serum level of at least one cholesterol level in a patient in need thereof, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein said cholesterol level is total cholesterol level, low-density lipoprotein (LDL) level, or triglyceride level.
A method of treating primary biliary cholangitis (PBC) in a patient in need thereof, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of one or more statins, to the patient.
A method of increasing expression level of one or more genes selected from OCTN2, CPT1A, CPT2, CACT, and CRAT, comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof.
A method of determining activities of seladelpar in a subject, comprising measuring the serum level of one or more of metabolites selected from the group consisting of:
- carnitine, acetylcarnitine, other acylcarnitines (i.e., short-, medium- and long-chain acylcarnitines), N,N,N-trimethyl-5-aminovalerate (TMAVA), branched-chain amino acid catabolites, dicarboxylates, saturated and unsaturated fatty acids, and lipid-derived inflammatory mediators.
A method of determining activities of seladelpar in a subject, comprising measuring the serum level of the expression level of one or more genes selected from OCTN2, CPT1A, CPT2, CACT, and CRAT in the subject.
A method of treating primary biliary cholangitis (PBC) in a patient in need thereof, comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to a subject, and measuring (a) the serum level of one or more of metabolites selected from the group consisting of:
- carnitine, acetylcarnitine, other acylcarnitines (i.e., short-, medium- and long-chain acylcarnitines), N,N,N-trimethyl-5-aminovalerate (TMAVA), branched-chain amino acid catabolites, dicarboxylates, saturated and unsaturated fatty acids, and lipid-derived inflammatory mediators;
- and/or (b) the expression level of one or more genes selected from OCTN2, CPT1A, CPT2, CACT, and CRAT in the subject.
A method of treating primary biliary cholangitis (PBC) in a patient in need thereof, the method comprising administering a therapeutically effective amount of seladelpar or a pharmaceutically acceptable salt thereof to the patient, wherein:
- (a) the patient is less than 65 years old, or 65 years old or older;
- (b) the patient was less than 50 years old at PBC diagnosis, or 50 years old or older;
- (c) the patient is white, Asian, black, Latino, or non-Latino;
- (d) the patient is male or female;
- (e) the patient is from North America, Europe, or rest-of-world;
- (f) the patient has serum ALP level of <350 U/L or ≥350 U/L at baseline;
- (g) the patient has Total Bilirubin (TB) level of <0.6×ULN or ≥0.6×ULN at baseline;
- (h) the patient has Total Bilirubin (TB) level of <1×ULN or ≥1×ULN at baseline;
- (i) the patient has pruritus NRS of <4 or ≥4 at baseline;
- or
- (j) the patient has cirrhosis or does not have cirrhosis.
Dependencies are inferred from the claim text.