Claims for Patent: 10,583,190

Summary for Patent: 10,583,190

Title:	Methods of treating psoriasis using IL-17 antibodies
Abstract:	The disclosure relates to novel regimens for treating psoriasis, which employ a therapeutically effective amount of an IL-17 antagonist, e.g., an IL-17 binding molecule, e.g., an IL-17 antibody, such as the secukinumab antibody, or an IL-17 receptor binding molecule, e.g., an IL-17 receptor antibody.
Inventor(s):	Guettner; Achim (Binzen, DE), Machacek; Matthias (Allschwil, CH), Papavassilis; Charis (Loerrach, DE), Sander; Oliver (Basel, CH)
Assignee:	NOVARTIS AG (Basel, CH)
Application Number:	15/630,577
Patent Claims:	1. A method of treating psoriasis, comprising subcutaneously administering to a patient in need thereof a dose of about 150 mg-about 300 mg of an IL-17 antibody weekly during week 0, 1, 2, 3, and 4, and then every four weeks thereafter, wherein the IL-17 antibody comprises: i) an immunoglobulin variable heavy (V.sub.H) domain comprising the amino acid sequence set forth as SEQ ID NO:8 and an immunoglobulin variable heavy (V.sub.L) domain comprising the amino acid sequence set forth as SEQ ID NO:10; ii) an immunoglobulin V.sub.H domain comprising the hypervariable regions set forth as SEQ ID NO:1, SEQ ID NO:2, and SEQ ID NO:3 and an immunoglobulin V.sub.L domain comprising the hypervariable regions set forth as SEQ ID NO:4, SEQ ID NO:5 and SEQ ID NO:6; or iii) an immunoglobulin V.sub.H domain comprising the hypervariable regions set forth as SEQ ID NO:11, SEQ ID NO:12 and SEQ ID NO:13 and an immunoglobulin V.sub.L domain comprising the hypervariable regions set forth as SEQ ID NO:4, SEQ ID NO:5 and SEQ ID NO:6; and wherein the IL-17 antibody binds to an epitope of an IL-17 homodimer having two mature IL-17 protein chains, said epitope comprising Leu74, Tyr85, His86, Met87, Asn88, Val124, Thr125, Pro126, Ile127, Val128, His129 on one chain and Tyr43, Tyr44, Arg46, Ala79, Asp80 on the other chain, wherein the IL-17 antibody has a K.sub.D of about 100-200 pM as measured by a biosensor system, and wherein the IL-17 antibody has an in vivo half-life of about about 23 to about 30 days. 2. The method of claim 1, wherein the dose of the IL-17 antibody is about 150 mg or about 300 mg. 3. The method of claim 2, wherein the dose of the IL-17 antibody is about 300 mg. 4. The method of claim 2, wherein the dose of the IL-17 antibody is about 150 mg. 5. The method of claim 2, wherein the dose of the IL-17 antibody is about 300 mg if the patient weighs more than 90 kg. 6. The method of claim 2, wherein the dose of the IL-17 antibody is about 300 mg if the patient weighs more than or equal to 90 kg. 7. The method of claim 2, wherein the dose of the IL-17 antibody is about 300 mg if the patient weighs more than 100 kg. 8. The method of claim 2, wherein the dose of the IL-17 antibody is about 150 mg if the patient weighs less than 90 kg. 9. The method of claim 2, wherein the dose of the IL-17 antibody is about 150 mg if the patient weighs less than or equal to 90 kg. 10. The method of claim 2, wherein the dose of the IL-17 antibody is about 150 mg if the patient weighs less than or equal to 100 kg. 11. The method according to claim 2, wherein, prior to treatment with the IL-17 antibody, the patient has not been previously treated with a systemic agent for psoriasis. 12. The method according to claim 2, wherein, prior to treatment with the IL-17 antibody, the patient has been previously treated with a systemic agent for psoriasis. 13. The method according to claim 12, wherein the systemic agent is selected from the group consisting of methotrexate, cyclosporine, fumaric acid esters, acitretin, alefacept, adalimumab, efalizumab, etanercept, infliximab, golimumab and ustekinumab. 14. The method according to claim 13, wherein the systemic agent is methotrexate. 15. The method of claim 2, wherein the patient has plaque psoriasis. 16. The method of claim 15, wherein the patient has moderate to severe plaque psoriasis. 17. The method according to claim 16, wherein, prior to treatment with the IL-17 antibody, the patient has an Investigator Global Assessment (IGA) score of .gtoreq.3. 18. The method of claim 16, wherein the patient is an adult patient. 19. The method of claim 2, wherein the patient has palm psoriasis, sole psoriasis, face psoriasis, scalp psoriasis, genital psoriasis, or nail psoriasis. 20. The method of claim 2, wherein the IL-17 antibody is comprised in a pharmaceutical formulation, wherein said pharmaceutical formulation further comprises a buffer and a stabilizer. 21. The method of claim 20, wherein the pharmaceutical formulation is in liquid form. 22. The method of claim 20, wherein the pharmaceutical formulation is a lyophilisate for reconstitution with an aqueous carrier prior to administration to the patient. 23. The method of claim 20, wherein the pharmaceutical formulation is contained within at least one pre-filled syringe, at least one vial, at least one injection pen, or at least one autoinjector. 24. The method of claim 20, wherein the dose of the IL-17 antibody is about 300 mg, wherein the pharmaceutical formulation is contained within an autoinjector, which is contained within a kit, and wherein said kit further comprises instructions for use. 25. The method of claim 20, wherein the dose of the IL-17 antibody is about 150 mg, wherein the pharmaceutical formulation is contained within a pre-filled syringe, an injection pen, or an autoinjector, which is contained within a kit, and wherein said kit further comprises instructions for use. 26. The method of claim 20, wherein the IL-17 antibody is secukinumab. 27. The method of claim 2, wherein the IL-17 antibody is a human monoclonal antibody. 28. The method of claim 27, wherein the IL-17 antibody is of the IgG.sub.1/kappa isotype. 29. The method of claim 2, wherein the IL-17 antibody has a T.sub.max of about 7-8 days. 30. The method of claim 2, wherein the IL-17 antibody has an absolute bioavailablilty of about 60-about 80%. 31. The method of claim 2, wherein the step of administering the IL-17 antibody every four weeks provides an average steady-state trough level of the IL-17 antibody between about 5 .mu.g/ml-about 70 .mu.g/ml. 32. The method of claim 31, wherein the step of administering the IL-17 antibody every four weeks provides an average steady-state trough level of the IL-17 antibody between about 5 .mu.g/ml-about 33 .mu.g/ml. 33. The method of claim 31, wherein the step of administering the IL-17 antibody every four weeks provides an average steady-state trough level of the IL-17 antibody between about 11 .mu.g/ml-about 70 .mu.g/ml.

Details for Patent 10,583,190

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2030-10-08
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2030-10-08
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2030-10-08
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2030-10-08
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2030-10-08
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2030-10-08