Combination product, salt, and use thereof in treating neurodegenerative diseases or disorders

A pharmaceutical composition, comprising:

• (a) a compound of formula (I) or a pharmaceutically acceptable salt, a solvate, a hydrate, or a stereoisomer thereof;
• wherein the compound of formula (I) is selected from:
• (b) a bile acid or a derivative of an analog thereof, or a pharmaceutically acceptable salt, a solvate, a hydrate, or a stereoisomer thereof;
• wherein the bile acid or the derivative or the analog thereof is selected from:
• cholic acid, obeticholic acid, ursodeoxycholic acid, chenodeoxycholic acid, hyodeoxycholic acid, 7-oxolithocholic acid, lithocholic acid, iododeoxycholic acid, iocholic acid, taurochenodeoxycholic acid, taurodeoxycholic acid, glycoursodeoxycholic acid, taurocholic acid, glycocholic acid, 24-norursodeoxycholic acid, and tauroursodeoxycholic acid;
• and
• (c) a pharmaceutically acceptable carrier, excipient, and/or diluent;
• wherein the molar ratio of the component (a) to the component (b) is 1:1000-1000:1.

An acid-base addition salt of formula (II):

• wherein
• (a) A+ is a cationic moiety selected from:
• (b) B− is an anionic moiety, of a bile acid or a derivative or an analog thereof;
• wherein the bile acid or the derivative or the analog thereof is selected from the group consisting of:
• cholic acid, obeticholic acid, ursodeoxycholic acid, chenodeoxycholic acid, hyodeoxycholic acid, 7-oxolithocholic acid, lithocholic acid, iododeoxycholic acid, iocholic acid, taurochenodeoxycholic acid, taurodeoxycholic acid, glycoursodeoxycholic acid, taurocholic acid, glycocholic acid, 24-norursodeoxycholic acid, and tauroursodeoxycholic acid;
• and
• (c) C− is an acid anion,
• wherein m, n, and p are each independently an integer selected from 1-6, such that the configuration of the salt reaches charge balance, and when m=n, p is 0.

A method for treating and/or preventing a neurodegenerative disease or disorder, comprising:

• regimen 1:
• administering to a patient in need thereof:
• (a) a therapeutically and/or prophylactically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt, a solvate, a hydrate, or a stereoisomer thereof wherein the compound of formula (I) is selected from:
• or
• regimen 2:
• administering to a patient in need thereof the following components simultaneously, concurrently, separately, or sequentially:
• (a) a therapeutically and/or prophylactically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt, a solvate, a hydrate, or a stereoisomer thereof;
• wherein the compound of formula (I) is selected from:
• (b) a therapeutically and/or prophylactically effective amount of a bile acid or a derivative or an analog thereof, or a pharmaceutically acceptable salt, a solvate, a hydrate, or a stereoisomer thereof:
• wherein the bile acid or the derivative or the analog thereof is selected from:
• cholic acid, obeticholic acid, ursodeoxycholic acid, chenodeoxycholic acid, hyodeoxycholic acid, 7-oxolithocholic acid, lithocholic acid, iododeoxycholic acid, iocholic acid, taurochenodeoxycholic acid, taurodeoxycholic acid, glycoursodeoxycholic acid, taurocholic acid, glycocholic acid, 24-norursodeoxycholic acid, and tauroursodeoxycholic acid.