IP Library Granted Patent US 10,835,506
Granted Patent B2
US 10,835,506 · App. 15/750,009 · Granted Nov 17, 2020

Treatment and prevention of muscle loss using L-ornithine in combination with at least one of phenylacetate and phenylbutyrate

Inventors: Christopher F. Rose (Montreal, CA); Franck Rousseau (Durham, NC)
Assignee: Ocera Therapeutics, Inc.
A61K31/198A61K9/0019A61K31/192A61P1/16A61P21/00C12Q1/42C12Q1/48A61K2300/00G01N2800/085
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Quick Facts
Patent No.
US 10,835,506
App. No.
15/750,009
Granted
Nov 17, 2020
Kind
B2
Abstract

Disclosed herein are methods of treating and preventing muscle loss using ornithine in combination with at least one of phenyl acetate and phenylbutyrate.

Claims (17)

1. A method of treating a condition of muscle loss, comprising administering ornithine in combination with at least one of phenylacetate and phenylbutyrate to a subject suffering from a condition of muscle loss, and thereby relieving the muscle loss condition.

2. The method of claim 1 , wherein the subject has received liver transplantation.

3. The method of claim 1 , wherein the subject is going to receive liver transplantation.

4. The method of claim 1 , further comprising determining muscle weight, muscle circumference, lean muscle, body weight, ammonia level, function(s) of one or more liver enzymes, fat mass, lean mass, brain water content, locomotor activity, protein synthesis rate, or any combination thereof of the subject.

5. The method of claim 4 , wherein the one or more liver enzymes comprise albumin, bilirubin, aspartate aminotransferase, alanine aminotransferase, phosphatase alkaline, or any combination thereof.

6. The method of claim 4 , wherein the brain water content is frontal cortex water content.

7. The method of claim 1 , at least one symptom of the condition of muscle loss is skeletal muscle loss or muscle mass loss.

8. The method of claim 1 , wherein the condition of muscle loss is caused by aging, disease, injury, inactivity, or any combination thereof.

9. The method of claim 1 , wherein the condition of muscle loss is sarcopenia, muscle atrophy, cachexia, muscular dystrophy, or any combination thereof.

10. The method of claim 1 , wherein the subject is suffering from chronic liver disease.

11. The method of claim 10 , wherein the chronic liver disease is cirrhosis.

12. The method of claim 1 , wherein the treatment of the condition comprises reducing blood ammonia, directly improving muscle metabolism, or a combination thereof.

13. The method of claim 1 , wherein separate pharmaceutically acceptable salts of the ornithine and at least one of phenylacetate and phenylbutyrate are administered to the subject.

14. The method of claim 13 , wherein the at least one of phenylacetate and phenylbutyrate is administered as a sodium phenylacetate or sodium phenylbutyrate.

15. The method of claim 1 , wherein the ornithine is administered as a free monomeric amino acid or physiologically acceptable salt thereof.

16. The method of claim 1 , wherein the ornithine and phenylacetate is administered as ornithine phenylacetate.

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

Assignments (14)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 25, 2024
From: OCERA THERAPEUTICS LLC
To: AMALIVE LIMITED
Reel/Frame 069017/0200 →
RELEASE OF SECURITY INTEREST Recorded Oct 7, 2024
From: ACQUIOM AGENCY SERVICES LLC
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 068810/0460 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2024
From: OCERA THERAPEUTICS, INC.
To: OCERA THERAPEUTICS LLC
Reel/Frame 066403/0804 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 049823, FRAME 0220 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 065609/0587 →
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 →
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 →
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 →
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: OCERA THERAPEUTICS
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049823/0220 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2018
From: ROSE, CHRISTOPHER F.; ROUSSEAU, FRANCK
To: OCERA THERAPEUTICS, INC.
Reel/Frame 045813/0066 →
Continuity (2)
Provisional Application 62206466 · Aug 18, 2015
Related Publication 20180221320A1 · Aug 9, 2018
Cited By (3)
US 12,396,675 US 12,516,015 US 12,697,317