Combination of ibudilast and riluzole and methods of using same
Inventors
Matsuda, Kazuko • Iwaki, Yuichi
Assignees
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Publication Number
US-11278531-B2
Publication Date
2022-03-22
Expiration Date
Abstract
The present disclosure relates generally to methods for treating neurodegenerative diseases, including their progressive forms. In particular, the present disclosure pertains to methods of treating or preventing neurodegenerative diseases, including their progressive forms and their associated symptoms by administering a combination of ibudilast (3-isobutyryl-2-isopropylpyrazolo[1,5-a]pyridine) and riluzole, or pharmaceutically acceptable salts of one or both thereof.
Core Innovation
The disclosure describes treating or preventing progressive neurodegenerative diseases by orally administering a combination therapy comprising ibudilast and riluzole, including pharmaceutically acceptable salts of each. The therapeutic purpose includes alleviating negative effects and slowing progression of disease, with amyotrophic lateral sclerosis (ALS) emphasized and other progressive neurodegenerative diseases also included in the disclosure.
The oral combination is administered in separate dosage forms or in the same dosage form, and may be administered simultaneously or consecutively. The composition aspect includes oral tablet, capsule, and oral liquid dosage forms, together with therapeutically effective amounts of ibudilast and riluzole and pharmaceutically acceptable salts.
The disclosure includes an experimental and evaluation framework supporting the therapeutic concept, including ALS model contexts using Drosophila life span and paraquat assays and mutant viability (VAP-33A mutants), rat model indications for Alzheimer’s, ALS, and Parkinson’s, and clinical trial design outlines for Alzheimer’s, ALS, Parkinson’s, and multiple sclerosis evaluating an ibudilast-riluzole combination versus placebo with ALSFRS, UPDRS, and EDSS outcome measures.
Claims Coverage
The independent claim covers one core inventive concept: treating a patient diagnosed with ALS by orally administering a therapeutically effective combination of ibudilast and riluzole, each optionally as a pharmaceutically acceptable salt. The inventive features are further defined by dosage-form arrangement, co-administration timing, dosage form type, and ibudilast dosing regimen.
Oral combination therapy for ALS using ibudilast and riluzole
A method of treating a patient diagnosed with amyotrophic lateral sclerosis (ALS) comprising orally administering a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of riluzole or a pharmaceutically acceptable salt thereof.
Separate dosage forms for oral co-administration
Ibudilast and riluzole, or pharmaceutically acceptable salts thereof, are administered in separate dosage forms.
Same dosage form for oral co-administration
Ibudilast and riluzole, or pharmaceutically acceptable salts thereof, are administered in the same dosage form.
Tablet, capsule, or liquid oral dosage form
Ibudilast and riluzole, or pharmaceutically acceptable salts thereof, are administered as a tablet, capsule, or liquid dosage form.
Simultaneous oral administration
Ibudilast and riluzole, or their pharmaceutically acceptable salts, are simultaneously administered.
Ibudilast dosing range split into portions
Ibudilast, or a pharmaceutically acceptable salt, is administered at 100 to 4,000 mg/day, split into one, two, or three portions.
Overall, the claim coverage centers on orally treating ALS with ibudilast and riluzole in therapeutically effective amounts, and narrows the combination by dosage-form arrangement, timing of administration, dosage form type, and a specific ibudilast daily dosing range divided into portions.
Stated Advantages
Alleviating negative effects in progressive neurodegenerative diseases.
Slowing progression of the disease.
Treating or preventing progressive neurodegenerative diseases, including ALS as emphasized in the disclosure.
Documented Applications
Treating a patient diagnosed with amyotrophic lateral sclerosis (ALS) using oral ibudilast-riluzole combination therapy.
Clinical trial design evaluation of an ibudilast-riluzole combination versus placebo in Alzheimer’s disease.
Clinical trial design evaluation of an ibudilast-riluzole combination versus placebo in amyotrophic lateral sclerosis (ALS).
Clinical trial design evaluation of an ibudilast-riluzole combination versus placebo in Parkinson’s disease.
Clinical trial design evaluation of an ibudilast-riluzole combination versus placebo in multiple sclerosis.
Rat model indication contexts for Alzheimer’s, ALS, and Parkinson’s.
Drosophila ALS model contexts using paraquat sensitivity, life span assay, and VAP-33A mutants.
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