# US 12,594,259 B2 · Treatment regimen for the treatment of neurological diseases or conditions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,259 B2 - Document ID: US12594259B2 - Status: Granted - Kind: B2 - Application number: 17/773,548 - Filed: 2020-10-29 - Published: 2022-12-08 - Granted: 2026-04-07 - Earliest claimed: 2019-10-30 - Assignees: Accure Therapeutics, S.L. - Applicants: Accure Therapeutics, S.L. - Inventors: Pablo Villoslada Diaz - Web page: https://patentgrep.com/patent/US12594259B2 ## CPC - A61K 31/4015: having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide - A61K 31/18: Sulfonamides (compounds containing a para-N-benzene-sulfonyl-N- group A61K31/63) - A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil - A61P 25/00: Drugs for disorders of the nervous system - A61P 27/02: Ophthalmic agents - A61P 27/06: Antiglaucoma agents or miotics - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract It relates to a compound of formula (I), or a pharmaceutically or veterinary acceptable salt thereof, or any stereoisomer or mixtures of stereoisomers, either of the compound of formula (I) or of any of its pharmaceutically or veterinary acceptable salts, wherein R1, R2, and R3 are as defined herein, for use in the treatment or prevention of a neurological disease or condition which results in the destruction or degeneration of neurons, axons or myelin, wherein the treatment comprises: a) a first time period from 1 to 7 days, wherein the compound is administered once or several times to a subject in need thereof, and b) a second time period equal to or longer than 13 days, wherein the compound is not administered wherein the second time period takes place after the first time period and before the next administration of the compound. ## Claims ### Claim 1 A method of treating a neurological disease or condition which results in the destruction or degeneration of neurons, axons or myelin; wherein the method comprises: administering a compound of formula (I) or a pharmaceutically acceptable salt thereof or pharmaceutical composition thereof, or any stereoisomer or mixtures of stereoisomers, either of the compound of formula (I) or of any of its pharmaceutically acceptable salts: wherein the compound of formula (I) is: wherein: R1 is phenyl substituted with halogen or trifluoromethyl, and further optionally substituted with one or two substituents selected from the group consisting of halogen, (C1-C6) alkyl, (C1-C6) alkoxy, and halo (C1-C6) alkyl; or alternatively R1 is pyrrolidin-1-yl; R2 is 2-oxo-pyrrolidin-1-ylmethyl or sulfamoylphenyl; and R3 is selected from the group consisting of propyl, 1-methylethyl, butyl, 2-methylpropyl, pentyl, 1-methylbutyl, 2-methylbutyl, hexyl, 4-methylpentyl, 3-methylpentyl, 2-methylpentyl, and 1-methylpentyl; wherein the method includes a discontinuous treatment regimen comprising: a) a first time period 5 to 7 days, wherein the compound is administered once a day to a subject in need thereof, and b) a second time period equal to or longer than 13 days, wherein the compound is not administered; and wherein the second time period takes place after the first time period and before the next administration of the compound; wherein the therapeutic effect of the treatment in the first time period extends through the second time period such that there is a neuroprotective effect during both the first time period and the second time period. ### Claim 2 (depends on 1) The method according to claim 1, wherein R3 is 2-methylpropyl. ### Claim 3 (depends on 2) The method according to claim 2, wherein the compound of formula (I) is selected from the group consisting of: or its pharmaceutically acceptable salt. ### Claim 4 (depends on 1) The method according to claim 1, wherein the first time period of step a) is 5 or 6 days. ### Claim 5 (depends on 4) The method according to claim 4, wherein the first time period is 7 days. ### Claim 6 (depends on 3) The method according to claim 3, wherein in step a) the compound of formula (I) or a pharmaceutically acceptable salt or pharmaceutical composition thereof, is BN201 . ### Claim 7 (depends on 6) The method according to claim 6, wherein in step a) the compound of formula (I) or a pharmaceutically acceptable salt or pharmaceutically acceptable composition thereof, is administered to treat acute optic neuritis. ### Claim 8 (depends on 1) The method according to claim 1, wherein the second time period is from 13 days to 89 days. ### Claim 9 (depends on 8) The method according to claim 8, wherein the second time period is 21 days. ### Claim 10 (depends on 1) The method according to claim 1, wherein the compound of formula (I) or a pharmaceutically acceptable salt or pharmaceutically acceptable composition thereof is administered intravenously. ### Claim 11 (depends on 1) The method according to claim 1, wherein the compound of formula (I) or a pharmaceutically acceptable salt or pharmaceutically acceptable composition thereof is administered intraperitoneally. ### Claim 12 (depends on 1) The method according to claim 1, wherein the disease or condition is selected from the group consisting of multiple sclerosis (MS), neuromyelitis optica (NMO), optic neuritis, transverse myelitis, Anterior Ischemic Optic Neuropathy, Dominant Optic Atrophy, toxic optic neuropathies, traumatic optic neuropathies, tumor-related optic neuropathies, Amyotrophic Lateral Sclerosis, and glaucoma. ### Claim 13 (depends on 12) The method according to claim 12, wherein the disease or condition is selected from the group consisting of multiple sclerosis (MS), neuromyelitis optica (NMO), optic neuritis, Anterior Ischemic Optic Neuropathy, and glaucoma. ### Claim 14 (depends on 6) The method of claim 6, wherein the disease is multiple sclerosis. ### Claim 15 (depends on 3) The method of claim 3, wherein the compound is BN201. ### Claim 16 (depends on 10) The method of claim 10, wherein the compound is BN201. ### Claim 17 (depends on 11) The method of claim 11, wherein the compound is BN201. ### Claim 18 (depends on 12) The method of claim 12, wherein the compound is BN201. ### Claim 19 (depends on 13) The method of claim 13, wherein the compound is BN201.