Protein biomarkers for lanadelumab treatment
AssigneeTakeda Pharmaceutical Company Limited
InventorsDaniel J. Sexton, Bin Li, Sin Kong Yeung
Life of this patent
Estimating the term…
Abstract
Provided herein are methods for determining whether a disorder is susceptible to treatment with a plasma kallikrein inhibitor and methods for identifying a subject as a candidate for treatment with a plasma kallikrein inhibitor. Provided herein are methods of identifying a subject as having or being at risk for a disorder and methods of treating a disorder in a subject. Also provided herein are methods of evaluating effectiveness of a treatment in a subject.
Claims85
A method for determining if a disorder is susceptible to treatment with a plasma kallikrein (pKal) inhibitor, comprising
- measuring the level of a biomarker set, which comprises at least one protein selected from Table 1, in a biological sample of a subject having the disorder, and
- identifying the disorder as being susceptible to treatment with a pKal inhibitor if the level of the biomarker set deviates from a reference value.
A method for identifying a subject as a candidate for treatment with a plasma kallikrein (pKal) inhibitor, comprising
- providing a biological sample from the subject having, suspected of having, or at risk of having a disorder, and
- measuring the level of a biomarker set, which comprises at least one protein selected from Table 1, in the biological sample,
- wherein if the level of the biomarker set in the biological sample deviates from a reference value, the subject is identified as a candidate for treatment with the pKal inhibitor.
A method for identifying a subject as having or at risk of having a disorder, comprising
- providing a biological sample from the subject, and
- measuring the level of a biomarker set, which comprises at least one protein selected from Table 1, in the biological sample,
- wherein if the level of the biomarker set in the biological sample deviates from the level of the biomarker set in a control sample, the subject is identified as having or at risk of the disorder.
A method for treating a disorder in a subject, comprising
- administering to the subject an effective amount of a plasma kallikrein (pKal) inhibitor,
- wherein the subject has a level of a biomarker set that deviates from the level of the biomarker set in a control sample,
- wherein the biomarker set comprises at least one protein selected from Table 1.
A composition for use in treating a subject having a disorder, the composition comprising a plasma kallikrein (pKal) inhibitor,
- wherein the subject has a level of a biomarker set that deviates from the level of the biomarker set in a control sample,
- wherein the biomarker set comprises at least one protein selected from Table 1.
A method for evaluating a treatment in a subject, comprising
- measuring the level of a biomarker set, which comprises at least one protein selected from Table 1, in biological samples obtained from the subject before and after the treatment or during the course of the treatment, and
- evaluating effectiveness of the treatment based on the level of the biomarker set, wherein a deviation level of the biomarker set after the treatment or over the course of the treatment as compared to before the treatment, indicates that the treatment is effective on the subject.
A method for analyzing a sample, the method comprising:
- (i) providing a set of biological samples obtained from a subject having, suspected of having, or being at risk for a disease associated with the contact activation system;
- and
- (ii) measuring the level of a biomarker set, which comprises at least one protein selected from Table 1, wherein if the biomarker set consists of one protein, said protein is not high molecular weight kininogen (KNG1), alpha-2-macroglobulin (A2M), complement C1q and tumor necrosis factor-related protein 9A (C1QTNF9), thrombin, or interleukin-21 (IL-21).
A kit for analyzing a sample of a subject having, suspected of having, or at risk for a disease associated with the contact system, the kit comprising:
- (i) a first binding agent specific to a first protein biomarker selected from Table 1;
- and
- (ii) a second binding agent specific to a second protein biomarker selected from Table 1;
- wherein the first protein biomarker and the second protein biomarker are different and are not both selected from the group consisting of 2-chain high molecular weight kininogen (KNG1), alpha-2-macroglobulin (A2M), complement C1q and tumor necrosis factor-related protein 9A (C1QTNF9), thrombin, and interleukin-21 (IL-21).
Dependencies are inferred from the claim text.