Advanced Protocol for Lupus Nephritis Relief

Introduction

This advanced treatment protocol provides a structured approach to managing lupus nephritis, a severe manifestation of lupus that affects kidney function and can lead to chronic health complications. By targeting specific pathways associated with inflammation and immune response, this protocol offers an effective strategy for reducing kidney damage, controlling symptoms, and improving patients’ quality of life. For companies in pharmaceuticals and biotechnology, this protocol represents a cutting-edge solution to address an unmet need in autoimmune disease management, particularly in nephrology and rheumatology fields.

The Challenge: Addressing Inflammation in Lupus Nephritis

Lupus nephritis, an inflammatory kidney condition stemming from lupus, is a complex disorder with limited treatment options. Patients with lupus nephritis often face significant challenges in managing kidney health, as standard treatments may not fully address the unique pathways involved in lupus-related inflammation. This leaves patients at risk of kidney damage, decreased renal function, and a reduced quality of life. As autoimmune disorders rise in prevalence, the need for more effective and targeted protocols that focus on symptom control, inflammation reduction, and kidney protection has become increasingly urgent.

Targeted Protocol for Symptom Management and Kidney Health

This protocol for lupus nephritis relief directly addresses these challenges by offering a structured approach that combines symptom control with inflammation management. It targets specific immune and inflammatory pathways that contribute to kidney damage, allowing for a more precise treatment method. Patients who follow this protocol experience reduced kidney inflammation, improved renal function, and better control of their lupus symptoms. By providing a clear, manageable pathway for patients and healthcare providers, this protocol supports long-term kidney health and helps alleviate the complexities associated with lupus nephritis treatment.

Key Benefits for Pharmaceuticals and Healthcare Providers

For pharmaceutical companies, this protocol opens doors to develop a suite of products tailored to the needs of lupus nephritis patients, positioning your company as a leader in nephrology and autoimmune disease management. Healthcare providers, especially nephrologists and rheumatologists, can integrate this protocol into their treatment options to deliver a comprehensive approach that supports better outcomes for patients. Its focus on inflammation reduction and kidney health preservation provides a distinct advantage over general lupus treatments, making it a valuable addition to the arsenal against autoimmune disorders.

Invest in Better Lupus Care

Licensing this protocol for lupus nephritis relief positions your company at the forefront of autoimmune disease treatment. By providing a structured, effective treatment option for managing lupus nephritis, your business can meet the demand for targeted therapies that enhance patient well-being and support long-term health. This protocol is a strategic investment for companies committed to advancing treatment solutions in nephrology, autoimmune diseases, and precision healthcare.

Please see terms and conditions

Abstract
Claims

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.

1-22. (canceled)

23. A method of treating lupus nephritis (LN) in a subject, 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 or 39.5 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) continuing the administering step b) to treat LN in the subject, wherein the voclosporin BID doses are reduced by 7.9 mg if, between the first and the second time points, the subject’s eGFR decreases in the range of ≥20% to ≤30% to below 60 ml/min/1.73 m².

24. The method of claim 23, 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.

25. The method of claim 23, wherein the voclosporin starting dose is 23.7 mg BID and the reduced dose is 15.8 mg BID.

26. The method of claim 23, wherein the voclosporin is a mixture of at least 90% E isomer and not more than 10% Z isomer.

27. The method of claim 23, wherein the corticosteroids are meth prednisolone and/or prednisone.

28. The method of claim 23, comprising continuing the administering step b) for a period of at least 16 weeks.

29. The method of claim 23, comprising continuing the administering step b for a period of at least 24 weeks.

30. The method of claim 23, comprising continuing the administering step b) for a period of at least 48 weeks.

31. The method of claim 23, comprising continuing the administering step b) for a period of at least 52 weeks.

32. The method of claim 23, 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 rag/mg.

33. The method of claim 23, wherein the selecting step a) comprises selecting a subject that has an eGFR of ≥45 mL/min/1.73 m²at the first time point.

34. The method of claim 23, further comprising assessing the subject’s eGFR at a third time point after initiating step d), and continuing the administering step b) to treat LN in the subject, wherein the voclosporin BID doses are reduced by 7.9 mg if, between the first and the third time points, the eGFR of the subject decreases in the range of ≥20% to ≤30% to below 60 ml/min/1.73 m².

35. A method of treating lupus nephritis (LN) in a subject, comprising:

c) assessing the subject’s eGFR at a second time point after initiating the administering step b); and

d) continuing the administering step b) to treat LN in the subject, wherein the voclosporin BID doses are reduced by 7.9 mg if between the first and the second time points the subject’s eGFR decreases in the range of ≥20% to ≤30% to below 60 ml/min/1.73 m², and wherein the administering is continued to achieve a urine protein creatinine ratio (U PCR) of ≤0.5 mg/mg.

36. The method of claim 35, 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.

37. The method of claim 35, wherein the voclosporin starting dose is 23.7 mg BID and the reduced dose is 15.8 mg BID.

38. The method of claim 35, wherein the voclosporin is a mixture of at least 90% E isomer and not more than 10% Z isomer.

39. The method of claim 35, wherein the corticosteroids are methylprednisolone and/or prednisone.

40. The method of claim 35, comprising continuing the administering step b) for a period of at least 16 weeks.

41. The method of claim 35, comprising continuing the administering step h) for a period of at least 24 weeks.

42. The method of claim 35, comprising continuing the administering step b) for a period of at least 48 weeks.

43. The method of claim 35, comprising continuing the administering step b for a period of at least 52 weeks.

44. The method of claim 35, 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) mg/mg.

45. The method of claim 35, wherein the selecting step a) comprises selecting a subject that has an eGFR of ≥45 mL/min/1.73 m²at the first time point.

Title

Protocol for treatment of lupus nephritis

Inventor(s)

Neil SOLOMONS, Robert B. HUIZINGA

Assignee(s)

Aurinia Pharmaceuticals Inc

Patent #

20220226428

Patent Date

July 21, 2022