Methods of reducing plasma level of macrophage migratory inhibitory factor in patients
Inventors
Iwaki, Yuichi • Matsuda, Kazuko
Assignees
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Publication Number
US-12213966-B2
Publication Date
2025-02-04
Expiration Date
Abstract
Disclosed is a method of reducing plasma level of macrophage migratory inhibitory factor in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of ibudilast, or a pharmaceutical salt thereof.
Core Innovation
The disclosure relates to reducing the plasma level of macrophage migratory inhibitory factor (MIF) in a subject by administering ibudilast or a pharmaceutically acceptable salt thereof. The subject is diagnosed with or suffering from severe viral-induced pneumonia, and the disclosure includes multiple administration routes and dosing regimens.
The problem being addressed is inflammatory disease associated with MIF, including severe viral-induced pneumonia and acute respiratory distress syndrome (ARDS). The disclosure specifically includes severe viral-induced pneumonia caused by a coronavirus, including coronavirus disease 2019 (COVID-19), and describes inflammatory conditions in which lowering plasma MIF is relevant.
The disclosure states that ibudilast is known for MIF allosteric inhibition and was unexpectedly found to lower plasma MIF. The disclosure includes clinical study examples measuring plasma MIF and other biomarkers, including a randomized double-blind placebo-controlled COVID-19 ARDS study and an ALS biomarker study, and reports statistically significant plasma MIF reduction versus placebo in a small subset.
Beyond severe viral-induced pneumonia and ARDS, the disclosure further encompasses conditions including cancer, microorganism infection, sepsis, neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), and autoimmune disorders. The text frames ibudilast in the context of reducing plasma MIF and links the treatment to biomarker changes measured in clinical examples.
Claims Coverage
Independent claim 1 recites a method of reducing plasma MIF in a subject with severe viral-induced pneumonia by administering ibudilast or a pharmaceutically acceptable salt. The dependent claims refine the administration route, numeric daily dose range, observation timing for plasma MIF reduction, and narrowing of viral etiology including COVID-19.
Reducing plasma level of macrophage migratory inhibitory factor in severe viral-induced pneumonia
A method of reducing plasma level of macrophage migratory inhibitory factor in a subject in need thereof, comprising administering a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt thereof, wherein the subject is diagnosed with or suffering from severe viral-induced pneumonia.
Oral administration of ibudilast
The method comprises administering ibudilast or a pharmaceutically acceptable salt thereof orally.
Therapeutically effective daily amount of ibudilast from 0.1 mg to 720 mg per day
The method includes administering a therapeutically effective daily amount of ibudilast or a pharmaceutically acceptable salt ranging from 0.1 mg to 720 mg per day.
Plasma MIF reduction observed within 12 hours after administration for 1 to 10 days
The method further includes observing a reduction in the subject’s plasma level of macrophage migratory inhibitory factor within 12 hours after administration of ibudilast given for 1 to 10 days.
COVID-19 as the coronavirus infection
The method is further limited to infection by a coronavirus specifically being COVID-19.
Overall, the claimed coverage centers on administering ibudilast or a pharmaceutically acceptable salt to reduce plasma macrophage migratory inhibitory factor in subjects with severe viral-induced pneumonia, with further refinements covering oral dosing, a specified daily dose range, the timing of observed plasma MIF reduction, and viral etiology narrowed to COVID-19.
Stated Advantages
Reducing the subject’s plasma level of macrophage migratory inhibitory factor.
Statistically significant plasma MIF reduction versus placebo is reported in a small subset in clinical study examples.
Documented Applications
Severe viral-induced pneumonia, including coronavirus including COVID-19, and acute respiratory distress syndrome (ARDS), with clinical study examples measuring plasma MIF and other biomarkers.
Neurodegenerative disease, including amyotrophic lateral sclerosis (ALS), with biomarker study examples measuring plasma MIF.
Cancer, microorganism infection, sepsis, and autoimmune disorders are encompassed as conditions associated with the disclosure’s plasma MIF reduction approach.
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