	US 11,815,516 B2
	Protein biomarkers for diseases associated with the contact activation system
Daniel J. Sexton, Melrose, MA (US); Malini Viswanathan, Acton, MA (US); Ryan Faucette, Melrose, MA (US); and Tripti Gaur, South Grafton, MA (US)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Appl. No. 16/333,155
Filed by Takeda Pharmaceutical Company Limited, Osaka (JP)
PCT Filed Sep. 15, 2017, PCT No. PCT/US2017/051749 § 371(c)(1), (2) Date Mar. 13, 2019, PCT Pub. No. WO2018/053244, PCT Pub. Date Mar. 22, 2018.
Claims priority of provisional application 62/518,492, filed on Jun. 12, 2017.
Claims priority of provisional application 62/395,712, filed on Sep. 16, 2016.
Prior Publication US 2021/0285962 A1, Sep. 16, 2021
Int. Cl. G01N 33/00 (2006.01); A61K 39/00 (2006.01); G01N 33/68 (2006.01); A61K 38/08 (2019.01); C07K 16/40 (2006.01)

CPC G01N 33/6893 (2013.01) [A61K 38/08 (2013.01); C07K 16/40 (2013.01); G01N 2333/47 (2013.01); G01N 2333/90 (2013.01); G01N 2333/99 (2013.01); G01N 2800/22 (2013.01); G01N 2800/52 (2013.01)]

18 Claims

1. A method, comprising:

(i) providing a biological sample obtained from a subject having or suspected of having hereditary angioedema (HAE); and

(ii) measuring the level of a protein biomarker set, which comprises Interleukin-36 alpha (IL-1F6);

(iii) identifying the subject as a patient having HAE if the level of IL-1F6 in the biological sample obtained from the subject is at least 1.1-fold lower than the level of IL-1F6 of a control subject, wherein the control subject is a subject not having HAE; and

(iv) administering to the subject identified as having HAE an effective amount of a therapeutic agent for treating HAE; wherein therapeutic agent is a plasma kallikrein (pKal) inhibitor, a bradykinin 2 receptor (B2R) inhibitor, and/or a C1 esterase inhibitor.