Granted Patent B2

US 12,655,207 · App. 17/734,482 · Granted Jun 16, 2026

Inventors: Julianty Angsana (San Diego, CA); Patrick Branigan (Lansdowne, PA); Samuel DePrimo (Carlsbad, CA); Susan Flavin (Spring City, PA); Shu Li (Dresher, PA); Xuejun Liu (San Diego, CA); Ernesto Munoz (Santa Fe, CA); Bruce Randazzo (Rydal, PA)

Assignee: Janssen Biotech, Inc.

C07K16/244A61K39/395A61P17/06C07K16/241A61K45/06C07K2317/21C07K2317/565

Abstract

Claims (36)

1 . A method of treating psoriasis in a patient, comprising administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, wherein the antibody to IL-23 comprises a light chain variable region and a heavy chain variable region, said light chain variable region comprising:

a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:50;

a CDRL2 amino acid sequence of SEQ ID NO:56; and

a CDRL3 amino acid sequence of SEQ ID NO:73,

said heavy chain variable region comprising:

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:5;

a CDRH2 amino acid sequence of SEQ ID NO:20; and

a CDRH3 amino acid sequence of SEQ ID NO:44, wherein the patient is treated with the antibody to IL-23 for at least 44 weeks to demonstrate greater efficacy in a psoriasis clinical endpoint than a patient treated with the antibody secukinumab.

2 . The method of claim 1 , wherein the psoriasis clinical endpoint is PASI90, PASI100, IGA 0 and/or IGA 1.

3 . The method of claim 2 , wherein the psoriasis clinical endpoint is measured 44 and/or 48 weeks after initial treatment with the antibody to IL-23.

4 . The method of claim 3 , wherein the psoriasis clinical endpoint is measured 48 weeks after initial treatment with the antibody to IL-23.

5 . The method of claim 1 , wherein the antibody to IL-23 is administered in an initial dose, 4 weeks after the initial dose and every 8 weeks after the dose at 4 weeks.

6 . The method of claim 1 , wherein the secukinumab antibody is administered in an initial dose, 1 week after the initial dose, 2 weeks after the initial dose, 3 weeks after the initial dose, 4 weeks after the initial dose and every 4 weeks after the dose at 4 weeks.

7 . The method of claim 1 , wherein the antibody to IL-23 is administered at a dose of 100 mg.

8 . The method of claim 7 , wherein the antibody to IL-23 is safe and effective treating psoriasis at an area of a patient selected from the group consisting of scalp, nails, hands and feet.

9 . The method of claim 7 , wherein the antibody to IL-23 is in a composition comprising 100 mg/mL of antibody; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state.

10 . The method of claim 9 , further comprising administering to the patient one or more additional drugs.

11 . The method of claim 10 , wherein the additional drug is selected from the group consisting of: immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers.

12 . The method of claim 1 , wherein the antibody to IL-23 is effective to induce clinical response, induce or maintain clinical remission, inhibit disease progression, or inhibit a disease complication in the patient.

13 . The method of claim 1 , wherein the patient is treated for moderate to severe psoriasis.

14 . The method of claim 1 , wherein the patient has psoriatic arthritis.

15 . A method of treating psoriasis in a patient, comprising administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, the antibody to IL-23 comprising a light chain variable region of the amino acid sequence of SEQ ID NO: 116 and a heavy chain variable region of the amino acid sequence of SEQ ID NO: 106, wherein the patient is treated with the antibody to IL-23 for at least 44 weeks to demonstrate greater efficacy in a psoriasis clinical endpoint than a patient treated with the antibody secukinumab.

16 . The method of claim 15 , wherein the psoriasis clinical endpoint is PASI90, PASI100, IGA 0 and/or IGA 1.

17 . The method of claim 15 , wherein the psoriasis clinical endpoint is measured 44 and/or 48 weeks after initial treatment with the antibody to IL-23.

18 . The method of claim 17 , wherein the psoriasis clinical endpoint is measured 48 weeks after initial treatment with the antibody to IL-23.

19 . The method of claim 15 , wherein the antibody to IL-23 is administered in an initial dose, 4 weeks after the initial dose and every 8 weeks after the dose at 4 weeks.

20 . The method of claim 15 , wherein the secukinumab antibody is administered in an initial dose, 1 week after the initial dose, 2 weeks after the initial dose, 3 weeks after the initial dose, 4 weeks after the initial dose and every 4 weeks after the dose at 4 weeks.

21 . The method of claim 15 , wherein the antibody to IL-23 is administered at a dose of 100 mg.

22 . The method of claim 21 , wherein the antibody to IL-23 is safe and effective treating psoriasis at an area of a patient selected from the group consisting of scalp, nails, hands and feet.

23 . The method of claim 21 , wherein the antibody to IL-23 is in a composition comprising 100 mg/mL of antibody; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state.

24 . The method of claim 23 , further comprising administering to the patient one or more additional drugs.

25 . The method of claim 24 , wherein the additional drug is selected from the group consisting of: immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers.

26 . The method of claim 15 , wherein the antibody to IL-23 is effective to induce clinical response, induce or maintain clinical remission, inhibit disease progression, or inhibit a disease complication in the patient.

27 . The method of claim 15 , wherein the patient is treated for moderate to severe psoriasis.

28 . The method of claim 15 , wherein the patient has psoriatic arthritis.

29 . A method of treating moderate-to-severe plaque psoriasis in an adult patient who is a candidate for systemic therapy or phototherapy, comprising administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, wherein the antibody comprises a light chain variable region of the amino acid sequence of SEQ ID NO: 116 and a heavy chain variable region of the amino acid sequence of SEQ ID NO: 106, the dosage is 100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter and the antibody is at a concentration of 100 mg/mL in a single-dose prefilled syringe comprising 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 and the diluent is water at standard state, wherein the patient is treated with the antibody to IL-23 for at least 44 weeks to demonstrate greater efficacy in a psoriasis clinical endpoint than a patient treated with the antibody secukinumab, the psoriasis clinical endpoint selected from the group consisting of PASI90, PASI100, IGA 0 and IGA 1.

Assignments (1)

Continuity (7)

References Cited (400)