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Publication Number
US-12171752-B2
Publication Date
2024-12-24
Expiration Date
Abstract
Disclosed is a method of treating post-COVID condition(s) in a patient in need thereof, the method comprising administering to the patient a therapeutically effective amount of ibudilast, or a pharmaceutical salt thereof.
Core Innovation
The invention relates to a method of treating post-COVID condition(s) in a patient comprising administering a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt thereof. The method is directed to treating post-COVID condition(s) in a patient who is SARS-CoV-2 negative and in need thereof, and the treatment is defined to reduce TNFα or IL-6 cytokine levels in the patient.
The post-COVID condition(s) comprise one or more symptoms selected from anxiety, fatigue, depression, shortness of breath, post-traumatic stress disorder, chest tightness, palpitations, smell or taste dysfunction, sleep difficulties, hair loss, and rash. The disclosed condition set includes sleep difficulties and specifies insomnia as an embodiment, and the disclosed symptom coverage includes cognitive impairment, including memory lapse and/or impaired concentration.
The disclosure further frames the ibudilast-based approach with reduction of inflammatory mediators, specifying TNFα or IL-6 cytokine reduction as part of the method. The described embodiments include multiple administration routes, therapeutically effective daily amount ranges, and dosing schedules, and the disclosure also includes optional combination therapy with one or more additional active agents.
Claims Coverage
The independent claim covers treating post-COVID condition(s) in a SARS-CoV-2 negative patient using ibudilast or a pharmaceutically acceptable salt to reduce TNFα or IL-6 cytokine levels. The claim scope includes a defined symptom set, and the dependent claims refine the treatment with dosage range constraints, dosing-splitting options, symptom subtypes, cognitive impairment, and optional combination therapy.
Treating post-COVID condition(s) in a SARS-CoV-2 negative patient
A method of treating post-COVID condition(s) in a SARS-CoV-2 negative patient in need thereof by administering a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt.
Reducing TNFα or IL-6 cytokine levels
Administering ibudilast or a pharmaceutically acceptable salt to reduce TNFα or IL-6 cytokine levels in the patient.
Symptom-defined post-COVID condition(s)
The post-COVID condition(s) comprise one or more of anxiety, fatigue, depression, shortness of breath, post-traumatic stress disorder, chest tightness, palpitations, smell or taste dysfunction, sleep difficulties, hair loss, or rash.
Therapeutically effective daily dosage range
Administering the therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt as a daily amount from 0.1 mg to 720 mg per day.
Single or split dosing schedule
Administering the therapeutically effective amount either as a single dose or split into two, three, or four doses.
Insomnia within sleeping difficulties
The method specifies that sleeping difficulties include insomnia.
Cognitive impairment in SARS-CoV-2 negative patients
The method is limited to a SARS-CoV-2 negative patient having a post-COVID condition of cognitive impairment.
Combination therapy with other active agents
The method includes at least one other active agent selected from a listed set, including corticosteroid, COX-2 inhibitor, NSAID, SSRI, SNRI, tricyclic antidepressant, antihistamine, beta-blocker, cannabidiol, ATP, ifenprodil tartrate, neurotropin, gabapentin, pregabalin, and mirtazapine, including combinations of two or more thereof.
Across the independent claim and refinements, the disclosed inventive scope centers on administering ibudilast or a pharmaceutically acceptable salt to SARS-CoV-2 negative patients to reduce TNFα or IL-6 cytokine levels, for post-COVID symptom sets that include anxiety, fatigue, depression, shortness of breath, post-traumatic stress disorder, chest tightness, palpitations, smell or taste dysfunction, sleep difficulties, hair loss, and rash, with further dependent refinements on dosage range, dosing split, insomnia, cognitive impairment, and optional combination therapy.
Stated Advantages
Reduces TNFα or IL-6 cytokine levels in the patient.
Documented Applications
Treating post-COVID condition(s) in a SARS-CoV-2 negative patient in need thereof, including symptom-based treatment covering anxiety, fatigue, depression, shortness of breath, post-traumatic stress disorder, chest tightness, palpitations, smell or taste dysfunction, sleep difficulties (including insomnia), hair loss, and rash.
Treating post-COVID cognitive impairment in SARS-CoV-2 negative patients.
Optional combination therapy for post-COVID condition(s) using ibudilast together with at least one other active agent selected from the listed set.
Early pilot/clinical study designs and mechanistic cytokine-release experiments involving reduction of TNFα and IL-6 in spike/LPS-stimulated settings across spike proteins (Wuhan, Delta, Omicron) are documented in the disclosure.
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