IP Library › Granted Patent US 9,763,919
Granted Patent B2
US 9,763,919 · App. 15/271,542 · Granted Sep 19, 2017

Detecting and treating growth hormone deficiency

Inventor: Michael Oliver Thorner (Charlottesville, VA)
Assignee: AMMONETT PHARMA, LLC
A61K31/435G01N33/74G01N2333/61G01N2333/65
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Quick Facts
Patent No.
US 9,763,919
App. No.
15/271,542
Granted
Sep 19, 2017
Kind
B2
Abstract

Described herein is a new oral method for using MK-0677 for detecting growth hormone (GH) deficiency (GHD). Also described is a method of treating growth hormone (GH) deficiency (GHD) in children with a functional hypothalamic-pituitary GH axis.

Claims (29)

1. A method of treating growth hormone deficiency (GHD) in children, comprising: administering a therapeutically effective amount of MK-0677 to a child known to have short stature and equivalent growth potential compared to rhGH, wherein a child has equivalent growth potential compared to rhGH when the child has:

(i.) a peak serum GH ≧5 μg/L in response to a single oral dose of MK-0677; and,

(ii.) a baseline serum IGF-I of >30 ng/mL.

2. The method of claim 1 , wherein a single, oral 0.8 mg/kg/d dose of MK-0677 is administered.

3. The method of claim 1 , wherein MK-0677 is orally administered via at least one mini-tablet, comprising: MK-0677.

4. The method of claim 3 , wherein the mini-tablet, comprises: 2 mg of MK-0677.

5. The method of claim 1 , wherein the GHD is pediatric GHD.

6. The method of claim 1 , wherein MK-0677 is orally administered and the orally administering, further comprises: administering with the assistance of a device capable of dispensing at least one MK-0677 mini-tablet.

7. A method of treating GHD in children, comprising:

a testing a child known to have short stature for GHD using a theranostic test; and,

b orally administering a therapeutically effective amount of MK-0677 to a child found to have short stature and equivalent growth potential compared to rhGH;

wherein a child has equivalent growth potential compared to rhGH when the child has:

(i.) a peak serum GH ≧5 μgL in response to a single oral dose of MK-0677; and,

(ii.) a baseline serum IGF-I of >30 ng/mL.

8. The method of claim 7 , wherein a single, oral 0.8 mg/kg/d dose of MK-0677 is administered.

9. The method of claim 7 , wherein MK-0677 is orally administered via at least one mini-tablet, comprising: MK-0677.

10. The method of claim 9 , wherein the mini-tablet, comprises: 2 mg of MK-0677.

11. The method of claim 7 , wherein the orally administering, further comprises: administering with the assistance of a device capable of dispensing at least one MK-0677 mini-tablet.

12. The method of claim 7 , wherein the GHD is pediatric GHD.

13. The method of claim 7 , wherein the theranostic test, comprises:

(iii.) testing for a peak serum GH ≧5 μg/L in response to a single oral dose of MK-0677; and,

(iv.) testing for a baseline serum IGF-I of >30 ng/mL.

14. The method of claim 13 , wherein a single, oral 0.8 mg/kg/d dose of MK-0677 is administered in step (i).

15. The method of claim 1 , wherein the treatment is maintained for more than 6 months.

16. The method of claim 1 , wherein the treatment is maintained for at least 7 months.

17. The method of claim 1 , wherein the treatment is maintained until growth potential is exhausted.

18. The method of claim 7 , wherein the treatment is maintained for more than 6 months.

19. The method of claim 7 , wherein the treatment is maintained for at least 7 months.

20. The method of claim 7 , wherein the treatment is maintained until growth potential is exhausted.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 10, 2018
From: AMMONETT PHARMA LLC
To: LUMOS PHARMA, INC.
Reel/Frame 046824/0501 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 17, 2017
From: THORNER, MICHAEL O
To: AMMONETT PHARMA LLC
Reel/Frame 043315/0167 →
Continuity (3)
Provisional Application 62289221 · Jan 30, 2016
Provisional Application 62221191 · Sep 21, 2015
Related Publication 20170079961A1 · Mar 23, 2017