Use of 1,3-propanedisulfonic acid or pharmaceutically acceptable salts thereof for the treatment of sarcoidosis

• US 10,682,321 B2
• Filed: 01/11/2019
• Issued: 06/16/2020
• Est. Priority Date: 04/30/2014
• Status: Active Grant

• Current Assignee: Icahn School of Medicine at Mount Sinai
• Original Assignee: Icahn School of Medicine at Mount Sinai
• Inventors: Morgenthau, Adam S.
• Primary Examiner(s): Rao, Savitha M
• Application Number:
  US16/246,231
• Publication Number:
  US 20190142774A1
• Time in Patent Office: 522 Days
• CPC Class Codes: A61K 31/185 Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids hydroxamic acids A61K31/16; peroxy acids A61K31/327
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

The present disclosure relates to methods for the treatment of sarcoidosis. In certain aspects and embodiments, the disclosure provides compositions containing 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof and/or the use of such compositions for the treatment of Sarcoidosis. In another aspect, the disclosure relates to compositions containing 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof plus a second active agent. In yet another aspect, the disclosure relates to kits containing agents useful for the treatment of sarcoidosis.

Claims

1. A method for inhibiting SAA-induced production of an inflammatory mediator in a subject, said method comprising administering to said subject an effective amount of 1,3-propanedisulfonic acid or a pharmaceutically acceptable salt thereof, wherein the inflammatory mediator is selected from IL-18, IL-10, and IL-TNF, and wherein the subject has sarcoidosis.

2. The method of claim 1 wherein said subject has chronic sarcoidosis.

3. The method of claim 1 wherein said sarcoidosis affects the lungs, liver, heart, nervous system, skin, lymph glands, musculoskeletal system, spleen, eyes, sinuses, nasal mucosa, larynx, the gastrointestinal tract, reproductive organs, salivary glands and/or kidneys.

4. The method of claim 3 wherein said sarcoidosis affects the lungs.

5. The method of claim 1 wherein at least 1 mg/kg of 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is administered to said subject per dose.

6. The method of claim 5 wherein said 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is administered more than once daily.

7. The method of claim 5 wherein said 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is administered 2, 3, 4, 5 or 6 times daily.

8. The method of claim 5 wherein no more than 20 mg/kg of 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is administered to said subject per dose.

9. The method of claim 1 wherein said 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is administered by oral, parenteral, intraperitoneal, intraspinal, intracerebral, nasal, mucosal, transdermal, intravascular, intraarterial, intramuscular, or subcutaneous delivery.

10. The method of claim 1 wherein said 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is administered by oral delivery.

11. The method of claim 1 wherein said 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is 1,3-propanedisulfonic acid.

12. The method of claim 1 wherein said 1,3-propanedisulfonic acid or pharmaceutically acceptable salt thereof is the disodium salt of 1,3-propanedisulfonic acid.