Pharmaceutical Formulation and Dosing Regimen for the Treatment of Amyotrophic Lateral Sclerosis
AssigneeAL-S Pharma AG
InventorsMarcel MAIER, Michael SALZMANN, Angela GENGE
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Abstract
Provided are pharmaceutical formulations and dosing regimen for antibody-based treatment of amyotrophic lateral sclerosis (ALS).
Claims51
A recombinant antibody that selectively binds to misfolded and/or aggregated forms of superoxide dismutase (SOD1) for use in the treatment of amyotrophic lateral sclerosis (ALS), wherein the treatment comprises administration of a dose of the antibody of about 2500 mg to a patient in need thereof.
The antibody for use according to any one of claims 1 to 27, wherein the antibody is administered in a formulation of any one of claims 29 to 47.
A liquid aqueous formulation of a recombinant antibody as defined in any one of the preceding claims that selectively binds to misfolded and/or aggregated forms of superoxide dismutase (SOD1), wherein the formulation is suitable for intravenous administration and comprises the antibody at a concentration of about 10 to 50 mg/ml in a L-histidine/L-histidine monohydrochloride buffer at a pH of about 6.0±1, wherein the antibody remains stable at 5° C.±2° C. for at least 1 month, at 25° C.±2° C. for at least 1 month, and/or at 40° C.±2° C. for 1 week.
Dependencies are inferred from the claim text.