IP Library Granted Patent US 10,525,029
Granted Patent B2
US 10,525,029 · App. 16/026,403 · Granted Jan 7, 2020

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

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Quick Facts
Patent No.
US 10,525,029
App. No.
16/026,403
Granted
Jan 7, 2020
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 (16)

1. A method of treating or delaying the onset or progression of a disease associated with hepatic stellate cell (HSC) activation, comprising administering an ammonia-lowering agent to a subject in need thereof, wherein the disease associated with HSC activation is non-alcoholic fatty liver disease (NAFLD), liver cancer, or fibrotic condition.

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 a fibrotic condition.

7. The method of claim 6 , wherein the fibrotic condition is liver fibrosis.

8. The method of claim 1 , wherein the ammonia-lowering agent comprises a magnesium phosphate product (MGP), glycerol phenylbutyrate (GPB), sodium phenylacetate, sodium phenylbutyrate (NaPBA), glutamine, sodium benzoate, L-arabinose, a laxative, an antibiotic, ornithine in combination with at least one of phenylacetate and phenylbutyrate, or any combination thereof.

9. The method of claim 8 , wherein the ammonia-lowering agent comprises ornithine in combination with at least one of phenylacetate and phenylbutyrate.

10. The method of claim 9 , wherein separate pharmaceutically acceptable salts of the ornithine and at least one of phenylacetate and phenylbutyrate are administered to the subject.

11. The method of claim 10 , wherein at least one of phenylacetate and phenylbutyrate is administered as a sodium phenylacetate or sodium phenylbutyrate.

12. The method of claim 9 , wherein the ornithine is administered as a free monomeric amino acid or physiologically acceptable salt thereof.

13. The method of claim 9 , wherein the ornithine and phenylacetate is administered as ornithine phenylacetate.

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

15. The method of claim 14 , wherein the administration is intravenous administration.

16. The method of claim 14 , wherein the administration is oral administration.

Assignments (9)
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: 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
Reel/Frame 072324/0740 →
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 →
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 →
CHANGE OF NAME Recorded Nov 27, 2019
From: UCL BUSINESS PLC
To: UCL BUSINESS LTD
Reel/Frame 051144/0324 →
CORRECTIVE ASSIGNMENT TO CORRECT THE FIFTH ASSIGNOR'S NAME PREVIOUSLY RECORDED AT REEL: 046263 FRAME: 0127. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jul 10, 2018
From: JALAN, RAJIV; MOOKERJEE, RAJESHWAR PROSAD; ROMBOUTS, KRISTA; ANDREOLA, FAUSTO; DE CHIARA, FRANCESCO; THOMSEN, KAREN LOUISE
To: UCL BUSINESS PLC
Reel/Frame 047376/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2018
From: JALAN, RAJIV; MOOKERJEE, RAJESHWAR PROSAD; ROMBOUTS, KRISTA; ANDREOLA, FAUSTO; CHIARA, FRANCESCO DE; THOMSEN, KAREN LOUISE
To: UCL BUSINESS PLC
Reel/Frame 046263/0127 →