Treatment of progressive neurodegenerative disease with ibudilast

Inventors

KALAFER, Michael E. • Locke, Kenneth W. • Matsuda, Kazuko • Gammans, Richard E.

Assignees

Medicinova Inc

Abstract

Compositions and methods for treating progressive neurodegenerative diseases, and their associated symptoms by administration of ibudilast (3-isobutyryl-2-isopropylpyrazolo[1,5-a]pyridine).

Core Innovation

The disclosed invention relates to methods for treating or preventing progressive neurodegenerative diseases with ibudilast, including progressive forms of multiple sclerosis and other adult or juvenile neurodegenerative disorders. The described problem is disability progression and disease progression in patients diagnosed with progressive forms of multiple sclerosis, including clinically measured disability worsening.

In particular, the document focuses on methods of reducing the likelihood of disability progression in a patient diagnosed with a progressive form of multiple sclerosis by administering a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt thereof. The document also describes treating Parkinson’s disease by administering a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt thereof.

The document states that ibudilast is associated with selective inhibition of cyclic nucleotide phosphodiesterases and anti-inflammatory and glial suppression, including suppression of glial activation such as microglia, astrocytes, and oligodendrocytes. It further describes clinical and biomarker outcomes from phase II multiple sclerosis studies using MRI features including brain volume loss, T1 and T2 lesions, gadolinium-enhancing lesions, and persistent brain “black holes,” along with disability progression measures such as EDSS.

The described treatment concepts include patient categories for progressive multiple sclerosis subtypes and duration constraints, and the document discusses administration routes including systemic administration, intrathecal administration, and oral route administration. The disclosure also references combination therapy and kit concepts and formulation concepts including sustained-release options and pharmaceutically acceptable salts for ibudilast.

Claims Coverage

The provided independent claims cover two therapeutic method categories based on ibudilast administration: reducing the likelihood of disability progression in progressive multiple sclerosis, and treating Parkinson’s disease. Across the independent claims, the core inventive requirement is administering a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt to a patient in need thereof, with dependent claims further specifying progressive MS subtypes, dosing duration, frequency, route, and a daily dosage range.

Overall, the claim set provided covers ibudilast-based treatment methods for progressive multiple sclerosis and Parkinson’s disease, with ibudilast or pharmaceutically acceptable salts administered at therapeutically effective amounts.

Stated Advantages

Documented Applications