IP Library Granted Patent US 11,364,277
Granted Patent B2
US 11,364,277 · App. 16/379,446 · Granted Jun 21, 2022

Treatment of ascites

Inventors: Paolo Angeli (Padua, IT); Penelope Markham (Clifton, VA); Jonathan Adams (Chicago, IL)
Assignee: BioVie Inc.
A61K38/095A61P1/00A61P1/16
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Quick Facts
Patent No.
US 11,364,277
App. No.
16/379,446
Granted
Jun 21, 2022
Kind
B2
Abstract

A method for treating ascites patients by administering the peptide drug terlipressin by continuous infusion. The patients include those whose ascites condition has not progressed to hepatorenal syndrome (HRS). Administration may be accomplished with a continuous infusion pump.

Claims (18)

1. A method for treating ascites in a non-hepatorenal syndrome (HRS) patient diagnosed with ascites due to liver cirrhosis, the method consisting of administering a monotherapy of a continuous infusion of terlipressin or salt thereof to the patient at a continuous infusion dose of about 0.8 mg to about 5.0 mg of terlipressin per day, wherein the patient is not hospitalized, and wherein the ascites in the patient is reduced.

2. The method of claim 1 , wherein the continuous infusion of terlipressin is administered with an ambulatory infusion pump.

3. The method of claim 1 , wherein the administration is provided on an out-patient basis.

4. The method of claim 1 , wherein the continuous infusion dose escalates over a treatment duration of about one day to about 12 months.

5. The method of claim 1 , wherein the continuous infusion is administered in a dose of about 3 mg of terlipressin per day.

6. The method of claim 1 , wherein the patient is not administered diuretics during a treatment duration with terlipressin.

7. The method of claim 1 , wherein the patient is further diagnosed with hyponatremia.

8. The method of claim 1 , wherein reduced ascites in the patient is indicated by a reduction in the frequency of paracentesis procedures after beginning a treatment duration with terlipressin.

9. The method of claim 1 , wherein reduced ascites in the patient is indicated by a reduction in the volume of ascitic fluid that is removed per paracentesis procedure after beginning a treatment duration with terlipressin.

10. The method of claim 1 , wherein reduced ascites in the patient is indicated by an increase in urinary sodium excretion during a treatment duration with terlipressin.

11. A method for reducing the accumulation of ascitic fluid in the abdominal cavity in an ascites, non-HRS patient, the method consisting of administering a monotherapy of a continuous infusion of terlipressin or salt thereof to the patient at a continuous infusion dose of about 0.8 mg to about 5.0 mg of terlipressin per day, wherein the patient is not hospitalized, and wherein reducing the accumulation of ascitic fluid in the abdominal cavity of the patient improves the ascites in the patient.

12. The method of claim 11 , wherein the terlipressin is administered for a treatment duration of about one day to about 12 months.

13. The method of claim 11 , wherein the continuous infusion of terlipressin is administered with an ambulatory infusion pump.

14. The method of claim 11 , wherein the administration is provided on an out-patient basis.

15. The method of claim 11 , wherein the continuous infusion dose escalates over a treatment duration of about one day to about 12 months.

16. The method of claim 11 , wherein the continuous infusion is administered in a dose of about 3 mg of terlipressin per day.

17. The method of claim 11 , wherein the patient is not administered diuretics during a treatment duration with terlipressin.

18. The method of claim 11 , wherein the patient is further diagnosed with hyponatremia.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Dec 6, 2024
From: AVENUE VENTURE OPPORTUNITIES FUND, L.P.
To: BIOVIE INC.
Reel/Frame 069510/0814 →
SECURITY INTEREST Recorded Dec 7, 2021
From: BIOVIE INC.
To: AVENUE VENTURE OPPORTUNITIES FUND, L.P.
Reel/Frame 058329/0389 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 24, 2019
From: UNIVERSITY OF PADOVA (A/K/A UNIVERSITA DEGLI STUDI DI PADOVA)
To: BIOVIE, INC.
Reel/Frame 049846/0554 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 29, 2019
From: ANGELI, PAOLO
To: UNIVERSITA DEGLI STUDI DI PADOVA
Reel/Frame 049307/0581 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 29, 2019
From: MARKHAM, PENELOPE; ADAMS, JONATHAN
To: BIOVIE INC.
Reel/Frame 049307/0628 →