Methods of treating chemical gas exposure

Inventors

Matsuda, Kazuko • Gaeta, Federico Carlos Aréjola

Assignees

Medicinova Inc

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Publication Number

US-11925625-B2

Patent

Publication Date

2024-03-12

Expiration Date


Abstract

A method of treating chemical-induced lung injury in a subject in need thereof includes administering to the subject a therapeutically effective amount of ibudilast, or a pharmaceutical salt thereof.

Core Innovation

The invention is directed to a method of treating chlorine-induced acute lung injury in a subject in need thereof by administering a therapeutically effective amount of ibudilast, or a pharmaceutical salt thereof, wherein the lung injury is acute respiratory distress syndrome. The disclosure identifies ibudilast as an anti-inflammatory agent for chemical-induced acute lung injury and relates this mechanism to the treatment context for chlorine-induced injury outcomes.

The disclosure provides preclinical efficacy using chlorine-exposed C57BL/6 mice and a chlorine-induced acute lung injury sheep model, including improvement in PaO2/FiO2 over time with MN-166 (ibudilast) versus controls. It also describes an example human assessment framework for response to ibudilast up to 100 mg.

Claims Coverage

The document includes one independent claim focused on treating chlorine-induced acute lung injury where the lung injury is acute respiratory distress syndrome, with dependent claims refining the administration regimen. Across the claim family, there are multiple inventive feature refinements relating to route, dosing range, and dosing schedule, as well as whether ibudilast is the sole active agent and whether an additional active agent such as a corticosteroid is used.

Treating chlorine-induced acute respiratory distress syndrome

A method of treating chlorine-induced acute lung injury in a subject in need thereof by administering a therapeutically effective amount of ibudilast, or a pharmaceutical salt thereof, wherein the lung injury is acute respiratory distress syndrome.

Daily dose range of ibudilast

Administering the therapeutically effective amount of ibudilast (or a pharmaceutically acceptable salt) at 0.1 mg to 720 mg per day.

Oral administration of ibudilast

Orally administering ibudilast or a pharmaceutically acceptable salt thereof.

Single or divided dosing schedule

Administering a therapeutically effective amount either as a single dose or divided into two, three, or four doses.

Sole administration of ibudilast

The method is administered using only ibudilast (or a pharmaceutically acceptable salt thereof) as the sole active agent.

Combination with a corticosteroid

The at least one additional active agent includes a corticosteroid.

Claim coverage centers on administering ibudilast (or a pharmaceutical salt) to treat chlorine-induced acute lung injury specifically when the lung injury is acute respiratory distress syndrome. Dependent features refine the regimen through explicit daily dosing range, route including oral, dose scheduling, whether ibudilast is the sole active agent, and optional combination therapy including a corticosteroid.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Treating chlorine-induced acute lung injury (including acute respiratory distress syndrome) using ibudilast.

Preclinical evaluation in chlorine-exposed C57BL/6 mice using MN-166 (ibudilast) and in a chlorine-induced acute lung injury sheep model, reporting improvement in PaO2/FiO2 over time.

Example human assessment framework for response to ibudilast up to 100 mg.

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