	US 12,138,272 B2
	Methods and compositions for treating amyotrophic lateral sclerosis
Joshua Cohen, Canton, MA (US); and Justin Klee, Cambridge, MA (US)
Assigned to Amylyx Pharmaceuticals, Inc., Cambridge, MA (US)
Filed by Amylyx Pharmaceuticals, Inc., Cambridge, MA (US)
Filed on May 12, 2022, as Appl. No. 17/742,707.
Prior Publication US 2023/0364110 A1, Nov. 16, 2023
Int. Cl. A61K 31/575 (2006.01); A61K 31/192 (2006.01); A61K 38/13 (2006.01)

CPC A61K 31/575 (2013.01) [A61K 31/192 (2013.01); A61K 38/13 (2013.01)]

11 Claims

1. A method of administering Taurursodiol (TURSO) and sodium phenylbutyrate to a human subject having at least one symptom of Amyotrophic Lateral Sclerosis (ALS) who has received a first dosage of cyclosporine, the method comprising:

(a) administering to the human subject a composition comprising about 1 gram of TURSO and about 3 grams of sodium phenylbutyrate,

(b) determining or having determined a first level of serum transaminases and/or bilirubin in a first biological sample from the human subject, and

(c) administering to the human subject a second dosage of cyclosporine, wherein the second dosage is lower than the first dosage,

wherein the subject has had onset of at least one symptom of ALS for more than about 24 months, and wherein the first dosage of cyclosporine is about 0.5 to about 15 mg/kg/day.