Methods of treating atopic dermatitis
Inventors
Harris, Sarah • Babcock, Erin • RODRIGUEZ, Cristian
Assignees
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Publication Number
US-11964005-B2
Publication Date
2024-04-23
Expiration Date
Abstract
The present disclosure is directed to methods of treating atopic dermatitis comprising administering to a subject in need thereof a therapeutically effective amount of an anti-IL-13 antibody, or antigen binding fragment thereof, thereby treating atopic dermatitis in the subject.
Core Innovation
The invention relates to methods for treating atopic dermatitis in a subject in need thereof by administering a therapeutically effective amount of an anti-IL-13 antibody or an antigen binding fragment thereof. The antibody antigen binding domain is defined by six CDRs, specifically CDR-H1, CDR-H2, CDR-H3, CDR-L1, CDR-L2, and CDR-L3, with each CDR comprising specified residues of SEQ ID NO:2 or SEQ ID NO:3.
A central embodiment is cendakimab, a recombinant humanized IgG1κ monoclonal antibody that neutralizes IL-13 by preventing IL-13 binding to IL-13Rα11 and IL-13Rα12. The antibody includes hinge/CH2 effector-reducing mutations L240A/L241A, and optional VH and VL sequences are described as mapped to SEQ ID NO:2 and SEQ ID NO:3.
The disclosed treatment approach is extended to symptom amelioration and incidence reduction in atopic dermatitis, including moderate to severe disease. Documented embodiments include pharmaceutical composition and treatment-selection concepts that incorporate biomarker-based monitoring of efficacy, including peripheral blood eosinophils, IgE, IL-13/IL-22, and TARC/PARC biomarker readouts (TARC/CCL17 and PARC/CCL18).
Claims Coverage
The claim set contains one independent claim directed to a method of treating atopic dermatitis by administering an anti-IL-13 antibody or antigen binding fragment with a six-CDR antigen-binding domain defined by specified residue ranges. The dependent claims refine the molecular identity of the antibody, identify a named embodiment, and specify subcutaneous administration.
Treatment of atopic dermatitis by administering a therapeutically effective anti-IL-13 antibody
A method of treating atopic dermatitis comprising administering to a subject in need thereof a therapeutically effective amount of an anti-IL-13 antibody, or antigen binding fragment thereof, thereby treating atopic dermatitis in the subject.
Six CDR-defined antigen binding domain with specified residues mapped to SEQ ID NO:2 and SEQ ID NO:3
The anti-IL-13 antibody comprises an antigen binding domain comprising six CDRs: CDR-H1, CDR-H2, CDR-H3, CDR-L1, CDR-L2, and CDR-L3, wherein CDR-H1 comprises residues 31-37 of SEQ ID NO:2; CDR-H2 comprises residues 52-67 of SEQ ID NO:2; CDR-H3 comprises residues 100-112 of SEQ ID NO:2; CDR-L1 comprises residues 24-34 of SEQ ID NO:3; CDR-L2 comprises residues 50-56 of SEQ ID NO:3; and CDR-L3 comprises residues 89-97 of SEQ ID NO:3.
Overall, the claim coverage is centered on treating atopic dermatitis with an anti-IL-13 antibody or antigen binding fragment defined by a six-CDR antigen-binding domain with CDRs specified by residue ranges mapped to SEQ ID NO:2 and SEQ ID NO:3. Additional claim refinements include specification of heavy and/or light chain variable domain sequences, optional L240A and L241A mutations, identification of cendakimab, and subcutaneous administration.
Stated Advantages
Neutralizes IL-13 by preventing IL-13 binding to IL-13Rα11 and IL-13Rα12.
Treats atopic dermatitis in the subject.
Ameliorates symptoms of atopic dermatitis.
Reduces incidence in atopic dermatitis.
Documented Applications
Treating atopic dermatitis, including moderate to severe atopic dermatitis, in adults in a Phase 2 randomized double-blind placebo-controlled study.
Biomarker-based monitoring of efficacy in atopic dermatitis using peripheral blood eosinophils, IgE, IL-13/IL-22, and TARC/PARC (TARC/CCL17 and PARC/CCL18).
Pharmaceutical composition manufacturing and treatment-selection concepts in the context of atopic dermatitis treatment.
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