Claims for Patent: 11,622,991

Summary for Patent: 11,622,991

Title:	Protocol for treatment of lupus nephritis
Abstract:	By employing a pharmacodynamic dosing regimen, the effectiveness of a protocol for treatment of a proteinuric kidney disease with voclosporin can be maximized while minimizing undesirable side effects.
Inventor(s):	Neil SOLOMONS, Robert B. HUIZINGA
Assignee:	Aurinia Pharmaceuticals Inc
Application Number:	US17/713,140
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,622,991
Patent Claims:	1. A method of treating lupus nephritis (LN) in a subject, the method comprising: a) selecting for treatment a subject having LN, the selecting comprising determining the subject's estimated Glomerular Filtration Rate (eGFR) at a first time point prior to initiating administering step b); b) administering to the subject voclosporin, mycophenolate mofetil (MMF), and corticosteroids, wherein the administering comprises administering the voclosporin at a starting dose of 23.7 mg administered orally twice daily (BID); c) assessing the subject's eGFR at a second time point after initiating the administering step b); and d) administering to the subject a reduced dose of 15.8 mg BID or 7.9 mg BID voclosporin to treat LN in the subject if, between the first and the second time points, the subject's eGFR decreases in the range of >20% to <30% below the subject's eGFR at the first time point to below 60 ml/min/1.73 m2. 2. The method of claim 1, comprising continuing the administering step b) for a period of at least 16 weeks and wherein the corticosteroids dose is not more than 2.5 mg/day by week 16. 3. The method of claim 1, wherein the reduced dose is 15.8 mg BID. 4. The method of claim 1, wherein the voclosporin is a mixture of at least 90% E isomer and not more than 10% Z isomer. 5. The method of claim 1, wherein the corticosteroids are methylprednisolone and/or prednisone. 6. The method of claim 1, comprising continuing the administering step b) for a period of at least 16 weeks. 7. The method of claim 1, comprising continuing the administering step b) for a period of at least 24 weeks. 8. The method of claim 1, comprising continuing the administering step b) for a period of at least 48 weeks. 9. The method of claim 1, comprising continuing the administering step b) for a period of at least 52 weeks. 10. The method of claim 1, wherein the selecting step a) further comprises determining the subject's UPCR prior to initiating the administering step b), and selecting a subject having LN that has a urine protein to creatinine ratio (UPCR) of ≥1.5 mg/mg. 11. The method of claim 1, wherein the selecting step a) comprises selecting a subject that has an eGFR of ≥45 mL/min/1.73 m2 at the first time point. 12. The method of claim 1, further comprising assessing the subject's eGFR at a third time point after initiating step d), and administering to the subject a reduced dose of 15.8 mg BID or 7.9 mg BID voclosporin if, between the first and the third time points, the eGFR of the subject decreases in the range of >20% to <30% below the subject's eGFR at the first time point to below 60 ml/min/1.73 m2. 13. The method of claim 1, comprising continuing to administer to the subject the dose of 23.7 mg BID voclosporin to treat LN in the subject if, between the first and the second time points, the subject's eGFR decreases by ≤20% below the subject's eGFR at the first time point. 14. A method of treating lupus nephritis (LN) in a subject, the method comprising: a) selecting for treatment a subject having LN, the selecting comprising determining the subject's estimated Glomerular Filtration Rate (eGFR) at a first time point prior to initiating administering step b); b) administering to the subject voclosporin, mycophenolate mofetil (MMF), and corticosteroids, wherein the administering comprises administering the voclosporin at a starting dose of 23.7 mg administered orally twice daily (BID); c) assessing the subjects eGFR at a second time point after initiating the administering step b); and d) administering to the subject a reduced dose of 15.8 mg BID or 7.9 mg BID voclosporin to treat LN in the subject if, between the first and the second time points, the subjects eGFR decreases in the range of >20% to <30% below the subject's eGFR at the first time point to below 60 ml/min/1.73 m2, and wherein the administering of d) achieves a urine protein creatinine ratio (UPCR) of <0.5 mg/mg. 15. The method of claim 1, wherein the reduced dose is 7.9 mg BID. 16. The method of claim 14, comprising continuing to administer to the subject the dose of 23.7 mg BID voclosporin to treat LN in the subject if, between the first and the second time points, the subject's eGFR decreases by ≤20% below the subject's eGFR at the first time point. 17. The method of claim 14, comprising continuing the administering step b) for a period of at least 16 weeks and wherein the corticosteroids dose is not more than 2.5 mg/day by week 16. 18. The method of claim 14, wherein the reduced dose is 15.8 mg BID. 19. The method of claim 14, wherein the voclosporin is a mixture of at least 90% E isomer and not more than 10% Z isomer. 20. The method of claim 14, wherein the corticosteroids are methylprednisolone and/or prednisone. 21. The method of claim 14, comprising continuing the administering step b) for a period of at least 16 weeks. 22. The method of claim 14, comprising continuing the administering step b) for a period of at least 24 weeks. 23. The method of claim 14, comprising continuing the administering step b) for a period of at least 48 weeks. 24. The method of claim 14, comprising continuing the administering step b) for a period of at least 52 weeks. 25. The method of claim 14, wherein the selecting step a) further comprises determining the subject's UPCR prior to initiating the administering step b), and selecting a subject having LN that has a urine protein to creatinine ratio (UPCR) of ≥1.5 mg/mg. 26. The method of claim 14, wherein the selecting step a) comprises selecting a subject that has an eGFR of ≥45 mL/min/1.73 m2 at the first time point. 27. The method of claim 14, wherein the reduced dose is 7.9 mg BID.