Treatment Of Inflammatory Bowel Disease In Subjects Having Loss-Of-Function (LOF) Gene Variants
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsAnna Alkelai, Alan Shuldiner, Joshua Backman, Antoine Baldassari
Life of this patent
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Abstract
The present disclosure generally relates to the treatment of subjects having IBD or at risk of developing IBD by administering an Indoleamine 2,3-Dioxygenase 2 (IDO2) agonist or a SMAD Family Member 2 (SMAD2) agonist to the subject.
Claims28
A method of treating a subject having Inflammatory Bowel Disease (IBD) or at risk of developing IBD, the method comprising administering an Indoleamine 2,3-Dioxygenase 2 (IDO2) agonist to the subject.
The method of claim wherein the subject is also administered an IBD therapeutic agent.
The method of 7claim 4, wherein the IDO2 variant nucleic acid molecule comprises the genetic variation 8:39989741:TG:T (Ala191fs), 8:39989787:C:T, or 8:39989793:A:T.
A method of treating a subject having Inflammatory Bowel Disease (IBD) or at risk of developing IBD by administering an IBD therapeutic agent, the method comprising:
- determining or having determined whether the subject has an Indoleamine 2,3-Dioxygenase 2 (IDO2) variant nucleic acid molecule, by:
- obtaining or having obtained a biological sample from the subject;
- and
- performing or having performed a sequence analysis on the biological sample to determine if the subject has a genotype comprising an IDO2 variant nucleic acid molecule;
- and
- administering or continuing to administer the IBD therapeutic agent in an amount that is the same as a standard dosage amount to a subject that is IDO2 reference;
- or
- administering or continuing to administer the IBD therapeutic agent in an amount that is the same as or less than a standard dosage amount, and/or an IDO2 agonist to a subject that is heterozygous or homozygous for the IDO2 variant nucleic acid molecule;
- wherein the presence of the IDO2 variant nucleic acid molecule indicates the subject has an increased risk of developing IBD.
10-11. (canceled)
A method of identifying a subject having an increased risk of developing Inflammatory Bowel Disease (IBD), the method comprising:
- determining or having determined the presence or absence of an Indoleamine 2,3-Dioxygenase 2 (IDO2) variant nucleic acid molecule in a biological sample obtained from the subject;
- wherein:
- when the subject is IDO2 reference, then the subject has a decreased risk of developing IBD;
- and
- when the subject is heterozygous or homozygous for the IDO2 variant nucleic acid molecule, then the subject has an increased risk of developing IBD.
15-25. (canceled)
A method of treating a subject having Inflammatory Bowel Disease (IBD) or at risk of developing IBD, the method comprising administering a SMAD Family Member 2 (SMAD2) agonist to the subject.
A method of treating a subject having Inflammatory Bowel Disease (IBD) or at risk of developing IBD by administering an IBD therapeutic agent, the method comprising:
- determining or having determined whether the subject has a SMAD Family Member 2 (SMAD2) variant nucleic acid molecule, by:
- obtaining or having obtained a biological sample from the subject;
- and
- performing or having performed a sequence analysis on the biological sample to determine if the subject has a genotype comprising a SMAD2 variant nucleic acid molecule;
- and
- administering or continuing to administer the IBD therapeutic agent in an amount that is the same as a standard dosage amount to a subject that is SMAD2 reference;
- or
- administering or continuing to administer the IBD therapeutic agent in an amount that is the same as or less than a standard dosage amount, and/or a SMAD2 agonist to a subject that is heterozygous or homozygous for the SMAD2 variant nucleic acid molecule;
- wherein the presence of the SMAD2 variant nucleic acid molecule indicates the subject has an increased risk of developing IBD.
35-36. (canceled)
A method of identifying a subject having an increased risk of developing Inflammatory Bowel Disease (IBD), the method comprising:
- determining or having determined the presence or absence of a SMAD Family Member 2 (SMAD2) variant nucleic acid molecule in a biological sample obtained from the subject;
- wherein:
- when the subject is SMAD2 reference, then the subject has a decreased risk of developing IBD;
- and
- when the subject is heterozygous or homozygous for the SMAD2 variant nucleic acid molecule, then the subject has an increased risk of developing IBD.
40-50. (canceled)
Dependencies are inferred from the claim text.