Methods Of Treating Metabolic Disorders And Cardiovascular Disease With Inhibin Subunit Beta E (INHBE) Inhibitors
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsLuca Andrea Lotta, Parsa Akbari, Olukayode Sosina, Manuel Allen Revez Ferreira, Aris Baras
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Abstract
The present disclosure provides methods of treating a subject having metabolic disorders and/or cardiovascular diseases, methods of identifying subjects having an increased risk of developing a metabolic disorder and/or a cardiovascular disease, and methods of detecting human Inhibin Subunit Beta E variant nucleic acid molecules and variant polypeptides.
Claims160
A method of treating a subject having or at risk of developing a metabolic disorder, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject having or at risk of developing type 2 diabetes, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject having or at risk of developing obesity, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject having or at risk of developing elevated triglyceride level, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject having or at risk of developing lipodystrophy, the methods comprising administering an Inhibin Subunit Beta E (INHBE) to the subject.
A method of treating a subject having or at risk of developing liver inflammation, the methods comprising administering an Inhibin Subunit Beta E (INHBE) to the subject.
A method of treating a subject having or at risk of developing fatty liver disease, the methods comprising administering an Inhibin Subunit Beta E (INHBE) to the subject.
A method of treating a subject having or at risk of developing hypercholesterolemia, the methods comprising administering an Inhibin Subunit Beta E (INHBE) to the subject.
A method of treating a subject having or at risk of developing an elevated liver enzyme, the methods comprising administering an Inhibin Subunit Beta E (INHBE) to the subject.
A method of treating a subject having or at risk of developing nonalcoholic steatohepatitis (NASH), the methods comprising administering an Inhibin Subunit Beta E (INHBE) to the subject.
A method of treating a subject having or at risk of developing a cardiovascular disease, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject having or at risk of developing cardiomyopathy, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject having or at risk of developing high blood pressure, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject having or at risk of developing heart failure, the method comprising administering an Inhibin Subunit Beta E (INHBE) inhibitor to the subject.
A method of treating a subject with a therapeutic agent that treats or inhibits a metabolic disorder, wherein the subject is suffering from a metabolic disorder, the method comprising the steps of:
- determining whether the subject has an Inhibin Subunit Beta E (INHBE) variant nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide by:
- obtaining or having obtained a biological sample from the subject;
- and
- performing or having performed a genotyping assay on the biological sample to determine if the subject has a genotype comprising the INHBE variant nucleic acid molecule;
- and
- when the subject is INHBE reference, then administering or continuing to administer to the subject the therapeutic agent that treats or inhibits the metabolic disorder in a standard dosage amount, and administering to the subject an INHBE inhibitor;
- and
- when the subject is heterozygous for an INHBE variant nucleic acid molecule, then administering or continuing to administer to the subject the therapeutic agent that treats or inhibits the metabolic disorder in an amount that is the same as or lower than a standard dosage amount, and administering to the subject an INHBE inhibitor;
- when the subject is homozygous for an INHBE variant nucleic acid molecule, then administering or continuing to administer to the subject the therapeutic agent that treats or inhibits the metabolic disorder in an amount that is the same as or lower than a standard dosage amount;
- wherein the presence of a genotype having the INHBE variant nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide indicates the subject has a decreased risk of developing the metabolic disorder.
A method of treating a subject with a therapeutic agent that treats or inhibits a cardiovascular disease, wherein the subject is suffering from a cardiovascular disease, the method comprising the steps of:
- determining whether the subject has an Inhibin Subunit Beta E (INHBE) variant nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide by:
- obtaining or having obtained a biological sample from the subject;
- and
- performing or having performed a genotyping assay on the biological sample to determine if the subject has a genotype comprising the INHBE variant nucleic acid molecule;
- and
- when the subject is INHBE reference, then administering or continuing to administer to the subject the therapeutic agent that treats or inhibits the cardiovascular disease in a standard dosage amount, and administering to the subject an INHBE inhibitor;
- and
- when the subject is heterozygous for an INHBE variant nucleic acid molecule, then administering or continuing to administer to the subject the therapeutic agent that treats or inhibits the cardiovascular disease in an amount that is the same as or lower than a standard dosage amount, and administering to the subject an INHBE inhibitor;
- when the subject is homozygous for an INHBE variant nucleic acid molecule, then administering or continuing to administer to the subject the therapeutic agent that treats or inhibits the cardiovascular disease in an amount that is the same as or lower than a standard dosage amount;
- wherein the presence of a genotype having the INHBE variant nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide indicates the subject has a decreased risk of developing the cardiovascular disease.
A method of identifying a subject having an increased risk for developing a metabolic disorder, wherein the method comprises:
- determining or having determined the presence or absence of an Inhibin Subunit Beta E (INHBE) variant nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide in a biological sample obtained from the subject;
- wherein:
- when the subject is INHBE reference, then the subject has an increased risk for developing the metabolic disorder;
- and
- when the subject is heterozygous or homozygous for an INHBE variant nucleic acid molecule, then the subject has a decreased risk for developing the metabolic disorder.
A method of identifying a subject having an increased risk for developing a cardiovascular disease, wherein the method comprises:
- determining or having determined the presence or absence of an Inhibin Subunit Beta E (INHBE) variant nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide in a biological sample obtained from the subject;
- wherein:
- when the subject is INHBE reference, then the subject has an increased risk for developing the cardiovascular disease;
- and
- when the subject is heterozygous or homozygous for an INHBE variant nucleic acid molecule, then the subject has a decreased risk for developing the cardiovascular disease.
A therapeutic agent that treats or inhibits a metabolic disorder for use in the treatment of the metabolic disorder in a subject having:
- an Inhibin Subunit Beta E (INHBE) variant genomic nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide;
- an INHBE variant mRNA molecule encoding an INHBE predicted loss-of-function polypeptide;
- or
- an INHBE variant cDNA molecule encoding an INHBE predicted loss-of-function polypeptide.
A therapeutic agent that treats or inhibits a cardiovascular disease for use in the treatment of the cardiovascular disease in a subject having:
- an Inhibin Subunit Beta E (INHBE) variant genomic nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide;
- an INHBE variant mRNA molecule encoding an INHBE predicted loss-of-function polypeptide;
- or
- an INHBE variant cDNA molecule encoding an INHBE predicted loss-of-function polypeptide.
An Inhibin Subunit Beta E (INHBE) inhibitor that treats or inhibits a metabolic disorder for use in the treatment of the metabolic disorder in a subject having:
- an Inhibin Subunit Beta E (INHBE) variant genomic nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide;
- an INHBE variant mRNA molecule encoding an INHBE predicted loss-of-function polypeptide;
- or
- an INHBE variant cDNA molecule encoding an INHBE predicted loss-of-function polypeptide.
An Inhibin Subunit Beta E (INHBE) inhibitor for use in the treatment and/or prevention of a metabolic disorder in a subject that:
- a) is reference for an INHBE genomic nucleic acid molecule, an INHBE mRNA molecule, or an INHBE cDNA molecule;
- or
- b) is heterozygous for:
- i) an INHBE variant genomic nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide;
- ii) an INHBE variant mRNA molecule encoding an INHBE predicted loss-of-function polypeptide;
- or
- iii) an INHBE variant cDNA molecule encoding an INHBE predicted loss-of-function polypeptide.
An Inhibin Subunit Beta E (INHBE) inhibitor that treats or inhibits a cardiovascular disease for use in the treatment of the cardiovascular disease in a subject having:
- an Inhibin Subunit Beta E (INHBE) variant genomic nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide;
- an INHBE variant mRNA molecule encoding an INHBE predicted loss-of-function polypeptide;
- or
- an INHBE variant cDNA molecule encoding an INHBE predicted loss-of-function polypeptide.
An Inhibin Subunit Beta E (INHBE) inhibitor for use in the treatment and/or prevention of a cardiovascular disease in a subject that:
- a) is reference for an INHBE genomic nucleic acid molecule, an INHBE mRNA molecule, or an INHBE cDNA molecule;
- or
- b) is heterozygous for:
- i) an INHBE variant genomic nucleic acid molecule encoding an INHBE predicted loss-of-function polypeptide;
- ii) an INHBE variant mRNA molecule encoding an INHBE predicted loss-of-function polypeptide;
- or
- iii) an INHBE variant cDNA molecule encoding an INHBE predicted loss-of-function polypeptide.
Dependencies are inferred from the claim text.