IP Library Granted Patent US 10,286,041
Granted Patent B2
US 10,286,041 · App. 15/383,969 · Granted May 14, 2019

ACTH prophylactic treatment of renal disorders

Inventors: Steve Cartt (Hayward, CA); Rujun Gong (Hayward, CA)
Assignees: Mallinckrodt ARD IP Limited; Rhode Island Hospital
A61K38/35A61K9/007A61K9/0014A61K9/0019A61K9/0031A61K9/0043A61K9/0053A61K9/06A61K38/16A61K38/1709A61K45/06C07K7/06C07K7/08C07K14/575C07K14/695
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Quick Facts
Patent No.
US 10,286,041
App. No.
15/383,969
Granted
May 14, 2019
Kind
B2
Abstract

Provided herein are methods for prophylactic treatment of renal disorders comprising administration of adrenocorticotropic hormone (ACTH), or fragment, analog, complex or aggregate thereof, or any combination thereof, to an individual suspected of having, predisposed to, or at risk of developing a renal disorder.

Claims (15)

1. A method of prophylactically treating acute kidney injury (AKI) in an individual in need thereof, comprising selecting an individual suspected of having, predisposed to, or at risk of developing acute kidney injury, and administering an adrenocorticotropic hormone (ACTH) peptide and a second therapeutic agent to the individual in need thereof, wherein the ACTH peptide is administered as a first dose and one or more subsequent doses, and wherein the ACTH peptide is an ACTH peptide preparation comprising ACTH peptides having about 90% or greater sequence identity with a full-length porcine ACTH sequence, wherein amino acids 1-13 of the ACTH peptide are amino acids 1-13 of SEQ ID NO: 1.

2. The method of claim 1 , wherein the ACTH peptides in the preparation are derived from porcine pituitary glands.

3. The method of claim 1 , wherein the ACTH peptide preparation is formulated in a gel.

4. The method of claim 1 , wherein the individual is undergoing surgery or has sepsis.

5. The method of claim 1 , wherein the selection of the individual is based upon a change in a kidney biomarker in the individual as compared to a normal baseline level of the kidney biomarker in the general population.

6. The method of claim 1 , wherein the selection of an individual is based upon a decrease in a glomerular filtration rate (GFR) level as compared to a normal baseline level, an increase in a serum creatinine level as compared to a normal baseline level, an increase in a urinary protein level as compared to a normal baseline level, an elevated asymmetric dimethylarginine (ADMA) level as compared to a normal baseline level, an elevated cystatin C (CysC) level as compared to a normal baseline level, an elevated C-reactive Protein (CRP) level as compared to a normal baseline level, or an elevated soluble tumor necrosis factor receptor II (sTNFrii) level as compared to a normal baseline level.

7. The method of claim 1 , wherein the selection of an individual is based upon detection of urinary neutrophil gelatinase-associated lipocalin (NGAL), detection of urinary interleukin-18 (IL-18), urinary kidney injury molecule-1 (KIM-1), or decreased urine output.

8. The method of claim 1 , wherein the first dose of the ACTH peptide preparation comprises a dose between about 10 IU and about 150 IU, and the one or more subsequent doses of the ACTH peptide preparation is administered about every day, about every 2 days, about every 5 days, about every week, about every two weeks, about every three weeks, about every month, about every two months, or any combination thereof.

9. The method of claim 1 , wherein the first dose of the ACTH peptide preparation comprises a dose between about 10 IU and about 150 IU, and the one or more subsequent doses of the ACTH peptide preparation are between about 20%-80% of the first dose.

10. The method of claim 1 , wherein the first dose of the ACTH peptide preparation comprises a first dose of between about 10 IU and about 150 IU, and the one or more subsequent doses of the ACTH peptide preparation are between about 20%-60% of the first dose.

11. The method of claim 1 , wherein the first dose and the one or more subsequent doses of the ACTH peptide preparation comprises a first dose of between about 10 IU and about 150 IU, and the one or more subsequent doses of the ACTH peptide preparation are between about 10 IU and about 80 IU, the first dose and the one or more subsequent doses of the ACTH peptide preparation are intermittent.

12. The method of claim 1 , wherein the second therapeutic agent is selected from the group consisting of an angiotensin-converting enzyme inhibitor, an angiotensin receptor blocker, a phosphate binder, a hepatocyte growth factor (HGF), a corticosteroid, erythropoietin, calcitriol, bardoxolone methyl, medoxomil, sulodexide and avosentan.

13. A method of treating renal damage caused by ischemia to the kidney in an individual in need thereof, comprising administering to the individual in need thereof an adrenocorticotropic hormone (ACTH) as an ACTH peptide preparation and a second therapeutic agent, wherein the ACTH peptide preparation has about 90% or greater sequence identity with a full-length porcine ACTH sequence, wherein amino acids 1-13 of the ACTH peptide are amino acids 1-13 of SEQ ID NO: 1, and wherein the ACTH peptide preparation is administered as a first dose and one or more subsequent doses.

14. The method of claim 13 , wherein the ACTH peptide preparation is formulated in a gel.

15. Previously presented) The method of claim 13 , wherein the second therapeutic agent is selected from the group consisting of an angiotensin-converting enzyme inhibitor, an angiotensin receptor blocker, a phosphate binder, a hepatocyte growth factor (HGF), a corticosteroid, erythropoietin, calcitriol, bardoxolone methyl, medoxomil, sulodexide and avosentan.

Assignments (21)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 075393/0058 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 73375 FRAME 395. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 075021/0263 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 72331 FRAME 1. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 075021/0204 →
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: SPECGX LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 049821, FRAME 0425 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065609/0176 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 043596, FRAME 0080 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065610/0188 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jul 22, 2019
From: MALLINCKRODT ARD IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049821/0425 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Aug 18, 2017
From: MALLINCKRODT ARD IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 043596/0080 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2017
From: ACTHAR IP
To: MALLINCKRODT ARD IP LIMITED
Reel/Frame 041444/0074 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2017
From: QUESTCOR PHARMACEUTICALS, INC.
To: ACTHAR IP
Reel/Frame 041443/0923 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2016
From: GONG, RUJUN
To: RHODE ISLAND HOSPITAL
Reel/Frame 041119/0291 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2016
From: CARTT, STEVE
To: QUESTCOR PHARMACEUTICALS, INC.
Reel/Frame 041118/0929 →
Continuity (4)
Continuation 14313903 · Jun 24, 2014
Continuation 13281175 · Oct 25, 2011
Provisional Application 61406550 · Oct 25, 2010
Related Publication 20170106053A1 · Apr 20, 2017
Cited By (3)
US 12,233,105 US 12,324,787 US 12,440,542