US2024016879A1PendingUtilityA1

Copper complexes for treatment of neurodegenerative disorders

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Assignee: ALS THERAPY DEVELOPMENT INSTPriority: Jul 25, 2019Filed: Apr 19, 2023Published: Jan 18, 2024
Est. expiryJul 25, 2039(~13 yrs left)· nominal 20-yr term from priority
A61K 38/02A61P 25/28A61K 9/1623A61K 31/555A61K 47/38A61K 47/26A61P 25/16A61P 25/14A61P 25/00
66
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Claims

Abstract

The present disclosure relates to the use of CuPTSM in methods and compositions for treating subjects with a neurodegenerative disease. Subjects with a neurodegenerative disease can have, e.g., amyotrophic lateral sclerosis (ALS).

Claims

exact text as granted — not AI-modified
1 . A method of treating or preventing a neurodegenerative disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of CuPTSM. 
     
     
         2 . The method of  claim 1 , wherein the neurodegenerative disease is amyotrophic lateral sclerosis (ALS), frontal temporal dementia (FTD), Parkinson's disease, Huntington's disease, and Alzheimer's disease. 
     
     
         3 . The method of  claim 1 , wherein the neurodegenerative disease is ALS. 
     
     
         4 . The method of  claim 3 , wherein the ALS is familial or sporadic. 
     
     
         5 . The method of any of  claim 1 , wherein the subject in need thereof is treatment naïve. 
     
     
         6 . The method of any of  claim 1 , wherein the subject in need thereof has received previous treatment for ALS. 
     
     
         7 . The method of  claim 1 , wherein the therapeutically effective dose of CuPTSM is 0.01 mg/kg/day-12 mg/kg/day. 
     
     
         8 . The method of any of  claim 1 , wherein the subject in need thereof is human, and the human has a genetic mutation associated with ALS. 
     
     
         9 . The method of  claim 8 , wherein the genetic mutation associated with ALS comprises a mutation in the SOD1 gene. 
     
     
         10 . The method of any of  claim 1 , wherein the CuPTSM is administered to the subject in combination with an additional ALS treatment therapy. 
     
     
         11 . The method of  claim 10 , wherein the CuPTSM is administered at a dose that achieves a plasma Cmax of about 50-640 ng/mL in the subject. 
     
     
         12 . A pharmaceutical composition comprising CuPTSM and a pharmaceutically acceptable excipient. 
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein the pharmaceutically acceptable excipient comprises cellulose and a surfactant. 
     
     
         14 . The pharmaceutical composition of  claim 13 , wherein the cellulose is methylcellulose. 
     
     
         15 . The pharmaceutical composition of  claim 13 , wherein the surfactant is a polysorbate. 
     
     
         16 . The pharmaceutical composition of  claim 15 , wherein the polysorbate is TWEEN. 
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein the TWEEN is TWEEN-80. 
     
     
         18 . A pharmaceutical composition comprising CuPTSM and a pharmaceutically acceptable excipient for use in the treatment of ALS in a subject in need thereof. 
     
     
         19 . The pharmaceutical composition of  claim 18 , wherein the pharmaceutically acceptable excipient comprises cellulose and a surfactant. 
     
     
         20 . The pharmaceutical composition of  claim 19 , wherein the cellulose is methylcellulose. 
     
     
         21 . The pharmaceutical composition of  claim 19 , wherein the surfactant is a polysorbate.

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