Anti-plasma kallikrein antibody dosing regimens for treating plasma kallikrein associated disorders
AssigneeAstria Therapeutics, Inc.
InventorsJou-Ku Chung, Christopher John Morabito, Andrew John Nichols
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Abstract
The invention describes methods for administering anti-plasma kallikrein antibodies, e.g., dosing regimens, to treat plasma kallikrein associated disorders, including hereditary angioedema (HAE).
Claims41
A method of treating a human subject having a plasma kallikrein associated disorder, comprising:
- administering a loading dose of 600-900 mg of an anti-plasma kallikrein antibody to the subject;
- and
- administering a maintenance dose of 150-450 mg of the anti-plasma kallikrein antibody to the subject beginning at least about 2 months after administering the loading dose and then at least about every 2 months thereafter;
- wherein the anti-plasma kallikrein antibody comprises:
- i) Complementarity Determining Sequences (CDRs) of a heavy chain variable region having the amino acid sequence of SEQ ID NO:
- 7, and CDRs of a light chain variable region having the amino acid sequence of SEQ ID NO:
- 8, wherein the antibody further comprises a constant region comprising an M252Y, an S254T, and a T256E mutation as numbered according to the EU numbering index;
- ii) an immunoglobulin heavy chain variable region comprising the amino acid sequence of SEQ ID NO:
- 7, and an immunoglobulin light chain variable region comprising the amino acid sequence of SEQ ID NO:
- 8, wherein the antibody further comprises a constant region comprising an M252Y, an S254T, and a T256E mutation as numbered according to the EU numbering index;
- or
- iii) an immunoglobulin heavy chain comprising the amino acid sequence of SEQ ID NO:9 and a light chain comprising the amino acid sequence of SEQ ID NO:10.
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A method of treating a human subject having a plasma kallikrein associated disorder, comprising:
- administering a first dose of 300-2,000 mg of an anti-plasma kallikrein antibody to the subject;
- and
- after a first period of time from administering the first dose,
- administering a second dose of 300-900 mg of the anti-plasma kallikrein antibody to the subject and thereafter, at intervals equal to the first period of time, administering one or more subsequent doses of 300-900 mg of the anti-plasma kallikrein antibody to the subject;
- wherein the first does, the second dose, and any one or more subsequent doses are the same amount;
- and
- wherein the anti-plasma kallikrein antibody comprises:
- i) Complementarity Determining Sequences (CDRs) of a heavy chain variable region having the amino acid sequence of SEQ ID NO:
- 7, and CDRs of a light chain variable region having the amino acid sequence of SEQ ID NO:
- 8, wherein the antibody further comprises a constant region comprising an M252Y, an S254T, and a T256E mutation as numbered according to the EU numbering index;
- ii) an immunoglobulin heavy chain variable region comprising the amino acid sequence of SEQ ID NO:
- 7, and an immunoglobulin light chain variable region comprising the amino acid sequence of SEQ ID NO:
- 8, wherein the antibody further comprises a constant region comprising an M252Y, an S254T, and a T256E mutation as numbered according to the EU numbering index;
- or
- iii) an immunoglobulin heavy chain comprising the amino acid sequence of SEQ ID NO:9 and a light chain comprising the amino acid sequence of SEQ ID NO:10.
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Dependencies are inferred from the claim text.