IP Library Granted Patent US 11,040,021
Granted Patent B2
US 11,040,021 · App. 16/732,861 · Granted Jun 22, 2021

Treatment of diseases associated with hepatic stellate cell activation using ammonia-lowering therapies

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Quick Facts
Patent No.
US 11,040,021
App. No.
16/732,861
Granted
Jun 22, 2021
Kind
B2
Abstract

Disclosed herein are methods of preventing, treating, and delaying the onset or progression of diseases associated with hepatic stellate cells (HSCs), such as non-alcoholic fatty liver disease (NAFLD), fibrosis, and liver cancer, using ammonia-lowering therapies.

Claims (19)

1. A method of treating or delaying the onset or progression of a disease associated with hepatic stellate cell (HSC) activation, comprising administering one or more ammonia-lowering agents to a subject in need thereof, wherein the ammonia-lowering agent is selected from the group consisting of sodium phenylacetate, sodium phenylbutyrate (NaPBA), sodium benzoate, a laxative, an antibiotic, ornithine in combination with at least one of phenylacetate and phenylbutyrate, and any combinations thereof, wherein the disease associated with HSC activation is non-alcoholic fatty liver disease (NAFLD), liver cancer or liver fibrosis.

2. The method of claim 1 , wherein the disease associated with HSC activation is non-alcoholic fatty liver disease (NAFLD).

3. The method of claim 2 , wherein the NAFLD is non-alcoholic steatohepatitis (NASH).

4. The method of claim 2 , wherein the NAFLD is steatosis.

5. The method of claim 1 , wherein the disease associated with HSC activation is liver cancer.

6. The method of claim 1 , wherein the disease associated with HSC activation is liver fibrosis.

7. The method of claim 1 , wherein the ammonia-lowering agent is ornithine phenylacetate.

8. The method of claim 7 , wherein ornithine phenylacetate is administered in combination with a laxative.

9. The method of claim 1 , wherein the administration is oral, intravenous, intraperitoneal, intragastric, or intravascular administration.

10. The method of claim 9 , wherein the administration is intravenous or oral administration.

11. A method of preventing non-alcoholic fatty liver disease (NAFLD), comprising administering one or more ammonia-lowering agents to a subject in need thereof, wherein the ammonia-lowering agent is selected from the group consisting of sodium phenylacetate, sodium phenylbutyrate (NaPBA), sodium benzoate, a laxative, an antibiotic, ornithine in combination with at least one of phenylacetate and phenylbutyrate, and any combinations thereof.

12. The method of claim 11 , wherein the NAFLD is non-alcoholic steatohepatitis (NASH) or steatosis.

13. The method of claim 11 , wherein the ammonia-lowering agent is ornithine in combination with phenylacetate.

14. The method of claim 13 , wherein separate pharmaceutically acceptable salts of the ornithine and phenylacetate are administered to the subject.

15. The method of claim 14 , wherein phenylacetate is administered as sodium phenylacetate.

16. The method of claim 14 , wherein the ornithine is administered as a free monomeric amino acid or physiologically acceptable salt thereof.

17. The method of claim 13 , wherein the ornithine in combination with phenylacetate is administered as ornithine phenylacetate.

18. The method of claim 11 , wherein the administration is oral, intravenous, intraperitoneal, intragastric, or intravascular administration.

19. The method of claim 18 , wherein the administration is intravenous or oral administration.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Nov 30, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); STRATATECH CORPORATION
Reel/Frame 065712/0988 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 052456, FRAME 0158 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 065609/0133 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2021
From: JALAN, RAJIV; MOOKERJEE, RAJESHWAR PROSAD; ROMBOUTS, KRISTA; ANDREOLA, FAUSTO; DE CHIARA, FRANCESCO; THOMSEN, KAREN LOUISE
To: UCL BUSINESS PLC
Reel/Frame 056285/0656 →
CHANGE OF NAME Recorded May 19, 2021
From: UCL BUSINESS PLC
To: UCL BUSINESS LTD
Reel/Frame 056399/0962 →
SECURITY INTEREST Recorded Apr 22, 2020
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; OCERA THERAPEUTICS, INC.; ST SHARED SERVICES LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 052463/0396 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Apr 21, 2020
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 052456/0158 →