IP Library Granted Patent US 12,600,772
Granted Patent B2
US 12,600,772 · App. 16/963,311 · Granted Apr 14, 2026

Therapeutic agent for asthma containing IL-6 inhibitor

Inventor: Motokazu Kato (Osaka, JP)
Assignee: Motokazu Kato
C07K16/248A61K39/395A61K45/06A61P11/00C07K16/2866
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Quick Facts
Patent No.
US 12,600,772
App. No.
16/963,311
Granted
Apr 14, 2026
Kind
B2
Abstract

The present invention provides therapeutic agents for treating human asthma through administration of an IL-6 inhibitor to humans. Representative IL-6 inhibitors in the present invention include IL-6 receptor antibodies and IL-6 antibodies. Therapeutic agents of the present invention can yield therapeutic effects in severe asthma patients who need administration of high-dose steroids and such for alleviation of symptoms, or even in patients whose symptoms are difficult to control by common treatment.

Claims (16)

1 . A method for treating human severe non-eosinophilic asthma, comprising administering 162 mg of an anti-IL-6 receptor antibody to a human adult subject in need thereof, wherein the anti-IL-6 receptor antibody is tocilizumab.

2 . The method of claim 1 , wherein tocilizumab comprises:

a) the heavy chain variable region of SEQ ID NO: 1 and the light chain variable region of SEQ ID NO: 2; or

b) the heavy chain variable region of SEQ ID NO: 5 and the light chain variable region of SEQ ID NO: 6.

3 . The method of claim 1 , wherein tocilizumab comprises:

a) the heavy chain of SEQ ID NO: 3 and the light chain of SEQ ID NO: 4, or

b) the heavy chain of SEQ ID NO: 7 and the light chain of SEQ ID NO: 8.

4 . The method of claim 1 , wherein the blood C-reactive protein (CRP) of the subject administered the anti-IL-6 receptor antibody is above normal level.

5 . The method of claim 1 , wherein the subject has rheumatoid arthritis.

6 . The method of claim 1 , wherein the administration results in:

suppression of at least one asthmatic symptom in the subject selected from coughing, wheezing, expectoration, and dyspnea;

a) improvement of respiratory function of the subject as measured by Peak Expiratory Flow (PEF); or

b) reduction in the amount of steroid use by the subject.

7 . The method of claim 1 , wherein the administration results in an improved Asthma Control Test (ACT) score in the subject and wherein the improved ACT score is 20 or greater.

8 . The method of claim 1 , wherein the anti-IL-6 receptor antibody is administered in combination with an inhaled steroid or a systemic steroid.

9 . The method of claim 1 , wherein the anti-IL-6 receptor antibody is administered in combination with an additional long-acting β2-agonist.

Priority Claims (2)
JP 2018-015983 · Jan 31, 2018 · national
JP 2018-187251 · Oct 2, 2018 · national
Continuity (1)
Related Publication 20210363238A1 · Nov 25, 2021
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Edwards et al. The remarkable flexibility of the human antibody repertoire; isolation of over one thousand different antibodies to a single protein, BLyS. Journal of Molecular Biology 334:103-118; (2003). (Year: 2003). [cited by examiner]
Lloyd et al. Modelling the human immune response: performance of a 10(11) human antibody repertoire against a broad panel of therapeutically relevant antigens. Protein Engineering, Eng. Design & Selection 22(3): 159-168… [cited by examiner]
Goel et al. Plasticity within the antigen-combining site may manifest as molecular mimicry in the humoral immune response. J. Immunol. 173: 7358-7367; (2004). (Year: 2004). [cited by examiner]
Khan et al. Adjustable locks and flexible keys: plasticity of epitope-paratope interactions in germline antibodies. J. Immunol. 192: 5398-5405; (2014) (Year: 2014). [cited by examiner]
Poosarla et al. teach Computational De Novo Design of Antibodies Binding to a Peptide With High Affinity. Biotechn. Bioeng. 114(6): 1331-1342; (2017). (Year: 2017). [cited by examiner]
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Almand, B., et al., “Increased Production of Immature Myeloid Cells in Cancer Patients: A Mechanism of Immunosuppression in Cancer,” J Immunol., 166:678-689 (2001). [cited by applicant]
Ano, S., et al., “Transcription Factors GATA-3 and RORγt Are Important for Determining the Phenotype of Allergic Airway Inflammation in a Murine Model of Asthma,” J Immunol., 190:1056-1065 (2013). [cited by applicant]
346: Anti-IL-6 treatment in two pediatric patients with severe persistent asthma with the IL4R576 variant, Presentation, AAAAI/WAO Joint Congress, Mar. 2-5, 2018, Orlando, FL, USA, https://aaaai.confex.com/aaaai/wao18/w… [cited by applicant]
ANZCTR, registered trial, Trial Review, Reg. No. ACTRN12614000123640, Registered Feb. 3, 2014. [cited by applicant]
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Chu, D. K., et al., “Therapeutic potential of anti-IL-6 therapies for granulocytic airway inflammation in asthma,” Allergy Asthma Clin Immunol., 11:14 (2015), 6 pages. [cited by applicant]
ClinicalTrials.gov, “A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma,” ID: NCT02794519, Sponsored by GlaxoSmithKline, Jun. 9, 2016. [cited by applicant]
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Habara, T., et al., “The biological effects of antiadhesion agents on activated RAW264.7 macrophages,” J Biomed Mater Res., 61:628-633 (2002). [cited by applicant]
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Hisanaga, K., “Neuro-Behcet disease and neuro-Sweet disease,” Clin Neurol., 52:1234-1236, (2012), English abstract. [cited by applicant]
Holmdahl, L., “The Role of Fribrinolysis in Adhesion Formation,” Eur J Surg., Suppl 577:24-31 (1997). [cited by applicant]
Hong, D. S., et al., “Interleukin-6 and Its Receptor in Cancer,” Cancer, 110:1911-1928 (2007). [cited by applicant]
Igawa, T., et al., “pH-dependent antigen-binding antibodies as a novel therapeutic modality,” Biochim Biophys Acta., 1844(11):1943-1950 (2014). [cited by applicant]
Ishikawa, S., et al., “[SAT0079] DNA Microarray of SLE Related Genes That Respond to IL-6 Blockade with Tocilizumab an Anti-IL-6 Receptor Monoclonal Antibody,” Ann Rheum Dis., 65(Suppl II):474 (2006). [cited by applicant]