Dosage forms of tissue kallikrein 1
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Publication Number
US-11857608-B2
Publication Date
2024-01-02
Expiration Date
Abstract
Provided are dosage forms of one or more tissue kallikrein-1 (KLK1) polypeptides which have a total KLK1 polypeptide dosage of about 0.1 μg/kg to about 10.0 μg/kg, including subcutaneous and intravenous dosage forms. Also provided are related devices and methods of use thereof, for example, for treating ischemic and hemorrhagic conditions.
Core Innovation
The invention relates to a method of treating an ischemic condition in a subject in need thereof by administering a dosage form comprising a first tissue kallikrein (KLK1) polypeptide and a second KLK1 polypeptide. The dosage form is administered subcutaneously or intravenously at a total KLK1 polypeptide dosage of 0.5 μg/kg to 5.0 μg/kg.
The first KLK1 polypeptide and the second KLK1 polypeptides differ by the pattern of N-linked glycans attached at residues 78, 84, and 141. In the dosage form, the first KLK1 polypeptide has three N-linked glycans attached at residues 78, 84, and 141 as defined by SEQ ID NO: 3 or 4, and the second KLK1 polypeptide has two N-linked glycans attached at residues 78 and 84 but not 141 as defined by SEQ ID NO: 3 or 4.
The first and second KLK1 polypeptides are present at a ratio of about 45:55 to about 55:45. The disclosed formulation is further characterized by defined KLK1 glycoform patterns, and the document emphasizes control of impurities and aggregates using measures including SEC HPLC.
Claims Coverage
The document contains one independent claim. It defines a treatment method for an ischemic condition with a dosage form comprising two KLK1 polypeptides having specific N-linked glycan attachment patterns and a defined ratio, administered subcutaneously or intravenously at a specified total KLK1 dosage range.
Ischemic condition treatment with dual KLK1 glycoform dosage form
A method of treating an ischemic condition in a subject in need thereof by subcutaneously or intravenously administering a dosage form comprising a first KLK1 polypeptide and a second KLK1 polypeptide, formulated at a total KLK1 polypeptide dosage of 0.5 μg/kg to 5.0 μg/kg, wherein the first KLK1 polypeptide has three N-linked glycans attached at residues 78, 84, and 141 as defined by SEQ ID NO: 3 or 4 and the second KLK1 polypeptide has two N-linked glycans attached at residues 78 and 84 but not 141 as defined by SEQ ID NO: 3 or 4, and wherein the first KLK1 polypeptide and the second KLK1 polypeptides are present at a ratio of about 45:55 to about 55:45.
Overall, the claim coverage centers on treating an ischemic condition using a subcutaneous or intravenous dosage form containing two KLK1 polypeptides with defined N-linked glycan patterns at residues 78, 84, and 141, together with a specified ratio and total KLK1 dosage range.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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