IP Library Granted Patent US 10,555,919
Granted Patent B2
US 10,555,919 · App. 15/525,375 · Granted Feb 11, 2020

Melatonin in autoimmune disease

Inventors: Mauricio Farez (Buenos Aires, AR); Francisco J. Quintana (Jamaica Plain, MA); Jorge Correale (Buenos Aires, AR)
Assignee: The Brigham and Women's Hospital, Inc.
A61K31/165A61K31/343A61K31/4045A61K45/06C07D209/16G01N33/74G01N2800/285G01N2800/50G01N2800/52
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Quick Facts
Patent No.
US 10,555,919
App. No.
15/525,375
Granted
Feb 11, 2020
Kind
B2
Abstract

Methods for treating, or reducing risk of developing, seasonal worsening of multiple sclerosis (MS) in a subject who has MS, comprising administering a melatonin agonist to a subject.

Claims (22)

1. A method of reducing seasonal worsening of MS in a subject who has MS, the method comprising:

identifying a subject who has a history of seasonal worsening of MS;

detecting a level of melatonin in a sample from the subject;

comparing the level of melatonin in the sample to a reference level of melatonin;

identifying the subject as having a level of melatonin below the reference level; and

administering a therapeutically effective amount of a melatonin agonist to the subject who has a level of melatonin below the reference level.

2. The method of claim 1 , wherein the reference level of melatonin is or corresponds to 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, or 24 ng/mg creatinine.

3. The method of claim 1 , wherein the melatonin agonist is ramelteon ((S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b] furan-8-yl)ethyl]propionamide), agomelatine (N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide), tasimelteon ((1R, 2R)—N-[2-(2,3-dihydrobenzofuran-4-yl)cyclopropylmethyl]propanamide), or TIK-301 (LY-156735) (N-[(2R)-(6-Chloro-5-methoxy-1H-indol-3-yl)propyl]acetamide).

4. The method of claim 1 , wherein the subject has one or more symptoms associated with seasonal worsening of their MS, has low melatonin levels, lives in a climate where a low-melatonin season is occurring or about to occur, or lives in a climate where melatonin levels are typically low.

5. The method of claim 1 , further comprising administering a REV-ERB agonist or a ROR agonist.

6. The method of claim 1 , wherein the melatonin agonist is administered orally, nasally, intravenously, or intrathecally.

7. The method of claim 1 , comprising detecting a level of 6-sulfatoxymelatonin (6-SM).

8. A method of decreasing levels of Th17 cells or increasing levels of Tr1 cells in a subject, the method comprising:

identify a subject who has a history of seasonal worsening of MS;

detecting a level of melatonin in a sample from the subject;

comparing the level of melatonin in the sample to a reference level of melatonin;

identifying the subject as having a level of melatonin below the reference level; and

administering a therapeutically effective amount of a melatonin agonist to the subject who has a level of melatonin below the reference level.

9. The method of claim 8 , wherein the melatonin agonist is ramelteon ((S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b] furan-8-yl)ethyl]propionamide), agomelatine (N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide), tasimelteon ((1R, 2R)—N-[2-(2,3-dihydrobenzofuran-4-yl)cyclopropylmethyl]propanamide), or TIK-301 (LY-156735) (N-[(2R)-(6-Chloro-5-methoxy-1H-indol-3-yl)propyl]acetamide).

10. The method of claim 8 , further comprising administering a REV-ERB agonist or a ROR agonist.

11. The method of claim 8 , wherein the melatonin agonist is administered orally, nasally, intravenously, or intrathecally.

12. The method of claim 8 , comprising detecting a level of 6-sulfatoxymelatonin (6-SM).

Assignments (3)
LICENSE Recorded Dec 20, 2024
From: BRIGHAM AND WOMEN'S HOSPITAL
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 069747/0795 →
CONFIRMATORY LICENSE Recorded Dec 11, 2018
From: BRIGHAM AND WOMEN'S HOSPITAL
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 049041/0876 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2018
From: FAREZ, MAURICIO; QUINTANA, FRANCISCO J.; CORREALE, JORGE
To: THE BRIGHAM AND WOMEN'S HOSPITAL, INC.
Reel/Frame 045129/0391 →
Continuity (2)
Provisional Application 62078473 · Nov 12, 2014
Related Publication 20170333371A1 · Nov 23, 2017