Methods and products for treating subjects with autism spectrum disorders
Inventors
Assignees
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Publication Number
US-11878016-B2
Publication Date
2024-01-23
Expiration Date
Abstract
Methods and products for treating a subject diagnosed with an autism spectrum disorder, an intellectual disability, an anxiety disorder, a mood disorder, a disorder of social interaction, irritability, aggression, self-injurious behavior, hyperactivity, inattention, or Fragile X syndrome or brain neuroinflammation by administering a tablet or liquid or a solid ODT or ODF or SMEDDS containing a ticagrelor or ticagrelor salt or combination with a second agent which may include a magnesium ion containing-compound, a zinc ion containing-compound, a lysine or lysine salt, an arginine or arginine salt, lecithin, or a combination thereof, wherein the ODT or ODF or SMEDDS releases >50% of the ticagrelor or a pharmaceutically acceptable salt thereof and >50% of the second agent within 15 minutes.
Core Innovation
The disclosed invention relates to methods and pharmaceutical products for treating autism spectrum disorder and related conditions, including intellectual disability, epilepsy, an anxiety disorder, a mood disorder, a disorder of social interaction, irritability, aggression, self-injurious behavior, hyperactivity, and inattention. The subject may also be diagnosed with Fragile X syndrome, or diagnosed with elevated TNFα or an elevated inflammatory cytokine marker of neuroinflammation. The treatment comprises administering ticagrelor, an enantiomer thereof, or a pharmaceutically acceptable salt thereof.
A central aspect of the invention is administering ticagrelor alone or in combination with a second agent, with the combination administered in a weight ratio of 1:0.1 to 1:50. The second agent is selected from magnesium ion containing-compounds, zinc ion containing-compounds, L-lysine or a salt thereof, L-arginine or a salt thereof, lecithin, or combinations thereof. The disclosed method for at least one embodiment excludes antioxidants from the administering.
The invention further includes oral dosage formats and delivery systems directed to rapid release of both actives, including orally disintegrating tablets (ODT), orally dissolving films (ODF), and self-microemulsifying drug delivery systems (SMEDDS). Documented formulations include low-dose ticagrelor regimens, as well as specific combination use with second agents such as zinc salts, including zinc caprylate-based SMEDDS.
Claims Coverage
The partial content provides three independent claims covering treating a broad set of neuropsychiatric/neurodevelopmental conditions and/or neuroinflammation-related biomarkers using ticagrelor alone or in combination with a second agent, with specific constraints on the combination ratio and, in one claim, exclusion of antioxidants. Across the independent claims, the main inventive features total four core aspects: target condition scope, ticagrelor-based administration, optional combination with a defined weight ratio, and defined selection/exclusion of second agents and antioxidants.
Treating specified disorders with ticagrelor without antioxidants
A method of treating a subject diagnosed with autism spectrum disorder or related conditions, including elevated TNFα or an elevated inflammatory cytokine marker of neuroinflammation, by administering ticagrelor, an enantiomer thereof, or a pharmaceutically acceptable salt thereof, or by administering a combination of ticagrelor with a second agent in a weight ratio of 1:0.1 to 1:50, wherein the administering does not include administering antioxidants.
Treating with ticagrelor plus selected second agent at defined weight ratio
A method of treating a subject diagnosed with autism spectrum disorder and related conditions, including elevated TNFα or an elevated inflammatory cytokine marker of neuroinflammation, by administering a combination of ticagrelor, an enantiomer thereof, or a pharmaceutically acceptable salt thereof with a second agent in a weight ratio of 1:0.1 to 1:50, wherein the second agent is selected from magnesium ion containing-compound, zinc ion containing-compound, L-lysine or a salt thereof, L-arginine or a salt thereof, lecithin, or a combination thereof.
Treating specified disorders with ticagrelor or ticagrelor-second agent combination
A method of treating a subject diagnosed with an intellectual disability and related conditions, including elevated TNFα or an elevated inflammatory cytokine marker of neuroinflammation, by administering ticagrelor, an enantiomer thereof, or a pharmaceutically acceptable salt thereof, or by administering a combination of ticagrelor with a second agent in a weight ratio of 1:0.1 to 1:50, wherein the second agent is selected from magnesium ion containing-compound, zinc ion containing-compound, L-lysine or a salt thereof, L-arginine or a salt thereof, lecithin, or a combination thereof.
Across the independent claims, coverage centers on treating specified disorders and/or neuroinflammation biomarkers using ticagrelor (or its enantiomers/salts) administered alone or with a second agent. Where combination therapy is used, the second agent is restricted to defined classes and combined within a weight ratio of 1:0.1 to 1:50, and one independent claim additionally excludes antioxidants from the administering.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating autism spectrum disorder and related neuropsychiatric/neuroinflammatory conditions by administering ticagrelor alone or with a second agent in a defined weight ratio, including oral dosage formats such as ODT, ODF, and SMEDDS.
Use in an in vivo valproic-acid autism mouse model with ticagrelor plus zinc salt, where sociability in a three-chamber test is improved.
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