US2022110948A1PendingUtilityA1

Compositions for improving cell viability and methods of use thereof

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Assignee: AMYLYX PHARMACEUTICALS INCPriority: Mar 24, 2013Filed: Dec 21, 2021Published: Apr 14, 2022
Est. expiryMar 24, 2033(~6.7 yrs left)· nominal 20-yr term from priority
Inventors:Joshua CohenJustin Klee
A61K 31/192A61P 25/28A61P 39/06A61K 2300/00A61K 9/0053A61K 31/575
77
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Claims

Abstract

This invention relates to methods and compositions for use improving cell viability, particularly neural cell viability, and more particularly to methods and compositions for use improving cell viability by reducing reactive oxygen metabolite-mediated oxidative damage in a cell, regulating redox homeostasis in a cell, or reducing mitochondrial dysfunction in a cell. The invention further relates to the administration of the bile acid tauroursodeoxycholic acid (TUDCA) in combination with phenylbutyric Acid (PBA) to improve cell viability, and treat at least one symptom associated with, prevent the time of onset of, or slow the development of a disease related to oxidative stress.

Claims

exact text as granted — not AI-modified
1 - 37 . (canceled) 
     
     
         38 . A method of treating at least one symptom of Amyotrophic Lateral Sclerosis (ALS) in a subject, the method comprising administering to the subject about 1 gram of tauroursodeoxycholic acid (TUDCA) once a day and about 3 grams of sodium phenylbutyrate once a day. 
     
     
         39 . The method of  claim 38 , wherein the TUDCA and sodium phenylbutyrate are administered as separate dosage forms. 
     
     
         40 . The method of  claim 38 , wherein the TUDCA and sodium phenylbutyrate are administered in a single dosage form. 
     
     
         41 . The method of  claim 38 , wherein the administering is oral administration. 
     
     
         42 . The method of  claim 38 , wherein the TUDCA and the sodium phenylbutyrate are administered to the subject for at least about 2 weeks. 
     
     
         43 . The method of  claim 38 , wherein the TUDCA and the sodium phenylbutyrate are administered to the subject for less than about three weeks. 
     
     
         44 . The method of  claim 38 , wherein the TUDCA and the sodium phenylbutyrate are administered to the subject for about 2 weeks to about 3 weeks. 
     
     
         45 . The method of  claim 38 , wherein the subject is human. 
     
     
         46 . The method of  claim 38 , wherein the subject is suspected as having ALS. 
     
     
         47 . A method of treating at least one symptom of ALS in a subject, the method comprising administering to the subject about 1 gram of TUDCA twice a day and about 3 grams of sodium phenylbutyrate twice a day. 
     
     
         48 . The method of  claim 47 , wherein the TUDCA and sodium phenylbutyrate are administered as separate dosage forms. 
     
     
         49 . The method of  claim 47 , wherein the TUDCA and sodium phenylbutyrate are administered in a single dosage form. 
     
     
         50 . The method of  claim 47 , wherein the administering is oral administration. 
     
     
         51 . The method of  claim 47 , wherein the method comprises administering to the subject about 1 gram of TUDCA twice a day and about 3 grams of sodium phenylbutyrate twice a day for at least about one week. 
     
     
         52 . The method of  claim 47 , wherein the method comprises administering to the subject about 1 gram of TUDCA twice a day and about 3 grams of sodium phenylbutyrate twice a day for at least about one month. 
     
     
         53 . The method of  claim 47 , wherein the subject is human. 
     
     
         54 . The method of  claim 47 , wherein the subject is suspected as having ALS. 
     
     
         55 . A method of treating at least one symptom of ALS in a subject, the method comprising administering to the subject about 1 gram of TUDCA once a day and about 3 grams of sodium phenylbutyrate once a day for about 2 weeks to about 3 weeks, followed by administering to the subject about 1 gram of TUDCA twice a day and about 3 grams of sodium phenylbutyrate twice a day. 
     
     
         56 . The method of  claim 55 , wherein the method comprises administering to the subject about 1 gram of TUDCA twice a day and about 3 grams of sodium phenylbutyrate twice a day for at least about one week. 
     
     
         57 . The method of  claim 55 , wherein the method comprises administering to the subject about 1 gram of TUDCA twice a day and about 3 grams of sodium phenylbutyrate twice a day for at least about one month. 
     
     
         58 . The method of  claim 55 , wherein the TUDCA and sodium phenylbutyrate are administered as separate dosage forms. 
     
     
         59 . The method of  claim 55 , wherein the TUDCA and sodium phenylbutyrate are administered in a single dosage form. 
     
     
         60 . The method of  claim 55 , wherein the administering is oral administration. 
     
     
         61 . The method of  claim 55 , wherein the subject is human. 
     
     
         62 . The method of  claim 55 , wherein the subject is suspected as having ALS.

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