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US 2024/0310377 A1Published application
Evaluation, assays and treatment of pkalmediated disorders
AssigneeTakeda Pharmaceutical Company Limited
InventorsKusumam Joseph, Allen A. Kaplan
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Abstract
The invention provides assay methods of detecting plasma protease C1 inhibitor (C1-INH) that binds plasma kallikrein, Factor XII, or both, and uses thereof for identifying subjects at risk for or suffering from a pKal-mediated or bradykinin-mediated disorder. Provided methods permit analysis of patients with plasma kallikrein-mediated angioedema (KMA), or other diseases mediated by pKal useful in the evaluation and treatment.
Claims21
1-39. (canceled)
A method for evaluating a treatment of a plasma kallikrein (pKal)-mediated disorder, the method comprising:
- (i) contacting biological samples obtained from a subject before treatment, after treatment, and/or during the course of treatment with a capture reagent, wherein the capture reagent comprises:
- a) an active form of Factor XII, or a C1-INH binding fragment thereof,
- b) an active form of pKal, or a C1-INH binding fragment thereof, or
- c) a combination of a) and b);
- (ii) measuring a level of the C1-INH in each of the biological samples that binds to the capture reagent;
- (iii) identifying the subject as not responsive to the treatment when the level of the C1-INH in the biological samples obtained after treatment or during the course of treatment decreases or remains the same as compared to the level of the C1-INH in the biological samples obtained before treatment;
- and
- (iv) administering to the subject identified in step (iii) a therapeutic agent for treating the pKal-mediated disorder.
5 more elements
Dependencies are inferred from the claim text.