IP Library › Granted Patent US 12,661,386
Granted Patent B2
US 12,661,386 · App. 18/061,066 · Granted Jun 23, 2026

Methods related to the treatment of IgA nephropathy

Inventors: Stephen Daniel Wax (Newton, MA); Roberto Bassi (Corte Madera, CA); Hans Guehring (Geisenheim, DE); Christopher Tehlirian (Newton, MA); Amy Hui-Chien Kao (Lexington, MA)
Assignee: Ares Trading S.A.
A61K38/1793A61P13/12C07K14/70578C07K19/00C07K2319/30
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Quick Facts
Patent No.
US 12,661,386
App. No.
18/061,066
Filed
Dec 2, 2022
Granted
Jun 23, 2026
Kind
B2
Art Unit
1647
USPC
424/134.1
Abstract

The present disclosure relates to methods related to the treatment of IgA nephropathy. More specifically, the present disclosure relates to methods for treating a patient having IgA nephropathy (IgAN), to methods for reducing the serum Gd-IgA1 level in a patient having IgA nephropathy (IgAN), to methods for reducing the proteinuria in a patient having IgA nephropathy, to methods for reducing the serum Gd-IgA1 level and the proteinuria in a patient having IgA nephropathy, and further related disclosure.

Claims (49)

1 . A method for treating a human patient having IgA nephropathy (IgAN), the method comprising:

administering to the human patient a therapeutically effective amount of atacicept, wherein:

(a) the atacicept is in an aqueous solution at a concentration of about 150 mg/ml;

(b) the atacicept solution has a pH of between about 4.9 and about 5.1;

(c) the patient has an estimated glomerular flow rate (eGFR) of about 35 mL/min/1.73 m2 or higher before the administration, wherein the eGFR is determined by a Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; and

(d) the administration results in an at least 25% reduction in the serum level of galactose deficient immunoglobulin A1 (Gd-IgA1) in the patient, compared to before the administration.

2 . The method of claim 1 , wherein the patient has persistent proteinuria.

3 . The method of claim 2 , wherein the persistent proteinuria is a persistent proteinuria of 1.0 to 6.0 g/day of total protein based on 24-hour urine collection.

4 . The method of claim 2 , wherein:

(a) the persistent proteinuria is a persistent proteinuria with a urine protein:creatinine ratio (UPCR) of ≥1 mg/mg based on 24-hour urine collection; or

(b) the persistent proteinuria is a persistent proteinuria with a UPCR of ≥0.75 mg/mg based on 24-hour urine collection, wherein at least once within 12 months prior to the administration, the patient has been determined to have a UPCR of ≥1 mg/mg based on 24-hour urine collection.

5 . The method of claim 1 , wherein the patient has been treated with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB), optionally for at least 8 weeks prior to the administration.

6 . The method of claim 1 , wherein the atacicept is administered at a dosage of at least 75 mg/week, optionally for a duration of at least 4 weeks.

7 . The method of claim 1 , wherein the atacicept is administered at a dosage of about 150 mg/week, optionally for a duration of at least 4 weeks.

8 . The method of claim 1 , wherein the route of administration is subcutaneous.

9 . The method of claim 1 , wherein the atacicept is obtained from mammalian cells comprising an expression construct encoding the atacicept.

10 . The method of claim 9 , wherein the mammalian cells are Chinese hamster ovary (CHO) cells.

11 . A method for treating a human patient having IgA nephropathy (IgAN), the method comprising administering to the human patient a therapeutically effective amount of atacicept, wherein:

(a) the atacicept is in an aqueous solution at a concentration of about 150 mg/ml;

(b) the atacicept solution has a pH of between about 4.9 and about 5.1;

(c) the patient has an estimated glomerular flow rate (eGFR) of about 35 mL/min/1.73m2 or higher before the administration, wherein the eGFR is determined by a Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; and

(d) the administration results in the Estimated Glomerular Filtration Rate (eGFR) of the patient (i) increasing, (ii) remaining stable, or (iii) decreasing by not more than 10%, compared to before the administration.

12 . The method of claim 11 , wherein the patient has persistent proteinuria.

13 . The method of claim 12 , wherein the persistent proteinuria is a persistent proteinuria of 1.0 to 6.0 g/day of total protein based on 24-hour urine collection.

14 . The method of claim 12 , wherein:

(a) the persistent proteinuria is a persistent proteinuria with a urine protein: creatinine ratio (UPCR) of ≥1 mg/mg based on 24-hour urine collection; or

(b) the persistent proteinuria is a persistent proteinuria with a UPCR of ≥0.75 mg/mg based on 24-hour urine collection, wherein at least once within 12 months prior to the administration, the patient has been determined to have a UPCR of ≥1 mg/mg based on 24-hour urine collection.

15 . The method of claim 11 , wherein the patient has been treated with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB), optionally for at least 8 weeks prior to the administration.

16 . The method of claim 11 , wherein the atacicept is administered at a dosage of at least 75 mg/week, optionally for a duration of at least 4 weeks.

17 . The method of claim 11 , wherein the atacicept is administered at a dosage of about 150 mg/week, optionally for a duration of at least 4 weeks.

18 . The method of claim 11 , wherein the route of administration is subcutaneous.

19 . The method of claim 11 , wherein the atacicept is obtained from mammalian cells comprising an expression construct encoding the atacicept.

20 . The method of claim 19 , wherein the mammalian cells are Chinese hamster ovary (CHO) cells.

21 . A method for treating a human patient having IgA nephropathy (IgAN), the method comprising administering to the human patient a therapeutically effective amount of atacicept, wherein:

(a) the atacicept is in an aqueous solution at a concentration of about 150 mg;ml;

(b) the atacicept solution has a pH of between about 4.9 and about 5.1;

(c) the patient has an estimated glomerular flow rate (eGFR) of about 35 mL/min/1.73m2 or higher before the administration, wherein the eGFR is determined by a Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; and

(d) the administration results in an at least a 25% reduction in urine protein: creatinine ratio (UPCR) based on a 24-hour urine collection, compared to before the administration.

22 . The method of claim 21 , wherein the patient has persistent proteinuria.

23 . The method of claim 22 , wherein the persistent proteinuria is a persistent proteinuria of 1.0 to 6.0 g/day of total protein based on 24-hour urine collection.

24 . The method of claim 22 , wherein:

(a) the persistent proteinuria is a persistent proteinuria with a urine protein: creatinine ratio (UPCR) of ≥1 mg/mg based on 24-hour urine collection; or

(b) the persistent proteinuria is a persistent proteinuria with a UPCR of ≥0.75 mg/mg based on 24-hour urine collection, wherein at least once within 12 months prior to the administration, the patient has been determined to have a UPCR of ≥1 mg/mg based on 24-hour urine collection.

25 . The method of claim 21 , wherein the patient has been treated with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB), optionally for at least 8 weeks prior to the administration.

26 . The method of claim 21 , wherein the atacicept is administered at a dosage of at least 75 mg/week, optionally for a duration of at least 4 weeks.

27 . The method of claim 21 , wherein the atacicept is administered at a dosage of about 150 mg/week, optionally for a duration of at least 4 weeks.

28 . The method of claim 21 , wherein the route of administration is subcutaneous.

29 . The method of claim 21 , wherein the atacicept is obtained from mammalian cells comprising an expression construct encoding the atacicept.

30 . The method of claim 29 , wherein the mammalian cells are Chinese hamster ovary (CHO) cells.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2022
From: KAO, AMY HUI-CHIEN
To: EMD SERONO RESEARCH AND DEVELOPMENT INSTITUTE, INC.
Reel/Frame 062060/0719 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2022
From: GUEHRING, HANS
To: MERCK HEALTHCARE KGAA
Reel/Frame 062060/0726 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2022
From: WAX, STEPHEN DANIEL; BASSI, ROBERTO; TEHLIRIAN, CHRISTOPHER
To: EMD SERONO RESEARCH AND DEVELOPMENT INSTITUTE, INC.
Reel/Frame 062060/0744 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2022
From: EMD SERONO RESEARCH AND DEVELOPMENT INSTITUTE, INC.
To: MERCK PATENT GMBH
Reel/Frame 062060/0751 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2022
From: MERCK HEALTHCARE KGAA
To: MERCK PATENT GMBH
Reel/Frame 062060/0755 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2022
From: MERCK PATENT GMBH
To: ARES TRADING S.A.
Reel/Frame 062060/0761 →
Continuity (3)
Continuation PCTUS2021035161 · Jun 1, 2021
Provisional Application 63033593 · Jun 2, 2020
Related Publication 20230210948A1 · Jul 6, 2023
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Clinical Trial NCT02808429 “Efficacy and Safety of Atacicept in IgA Nephropathy,” [online database] U.S. National Library of Medicine Clinical Trial NCT02808429, Version 10, (Dec. 18, 2017); last updated Feb. 25, 2021; … [cited by applicant]
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