Dosages and methods for delivering lipid formulated nucleic acid molecules
AssigneeAlnylam Pharmaceuticals, Inc.
InventorsPia Kasperkovitz, Jared Gollob
Life of this patent
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Abstract
Methods, kits and devices for dosing a subject to reduce a hypersensitivity response to a lipid-formulated nucleic acid (e.g., RNA) molecule are disclosed.
Claims34
A method of reducing an infusion-related response (IRR), or a hypersensitivity reaction, or both, in a subject, to a composition comprising a lipid formulation and a nucleic acid molecule, wherein the nucleic acid molecule comprises a double stranded RNA (dsRNA) molecule, said method comprising administering to a subject:
- a first dose of said composition;
- a second dose of said composition;
- wherein the amount of said composition administered in said first dose is no more than 1/10 of the amount of said composition administered in said second dose;
- and
- wherein one or both of a)-b) of the following conditions is met:
- a) the first dose is administered over a time period that is no more than ½ of the time period over which the second dose is administered;
- or
- b) the rate of administration of said first dose is no more than ½ of the rate of administration of said second dose.
A method of reducing the expression of a target gene, or treating a disorder related to the target gene, in a subject, the method comprising:
- administering to the subject a first dose and a second dose of a composition, said composition comprising a lipid formulation and a nucleic acid molecule, wherein the nucleic acid molecule comprises a double stranded RNA (dsRNA) molecule, and wherein said first and second doses are administered in an amount sufficient to reduce expression of a target gene, or treat the disorder, in the subject;
- wherein the amount of said composition administered in said first dose is no more than 1/10 of the amount of said composition administered in said second dose;
- and
- wherein one or both of a)-b) of the following conditions is met:
- a) the first dose is administered over a time period that is no more than ½ of the time period over which the second dose is administered;
- or
- b) the rate of administration of said first dose is no more than ½ of the rate of administration of said second dose.
A method of reducing an infusion-related response (IRR), or a hypersensitivity reaction, or both, in a subject, to a composition comprising a lipid formulation and a nucleic acid molecule, wherein the nucleic acid molecule comprises a double stranded RNA (dsRNA) molecule, said method comprising administering to a subject:
- a first dose of said composition;
- a second dose of said composition;
- wherein the amount of said composition administered in said first dose is between 8% and 12% of the amount of said composition administered in said second dose;
- wherein the first dose is administered over a time period that is no more than ½ of the time period over which the second dose is administered;
- and
- wherein the rate of administration of said first dose is no more than ½ of the rate of administration of said second dose.
Dependencies are inferred from the claim text.