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US 11,596,669 B2Granted
Liquid formulations comprising mutant FGF-21 peptide pegylated conjugates
Assignee89Bio Ltd
InventorsBoris Schwartsburd, Shaji Joseph
Life of this patent
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Abstract
The present disclosure relates to liquid pharmaceutical compositions comprising mutant Fibroblast Growth Factor-21 (FGF-21) peptide conjugate and prefilled syringe or autoinjector comprising liquid pharmaceutical compositions comprising mutant Fibroblast Growth Factor-21 (FGF-21) peptide conjugate.
Claims13
A prefilled syringe or autoinjector comprising a liquid pharmaceutical composition, the liquid pharmaceutical composition comprising:
- (a) 20 mg/ml of a mutant Fibroblast Growth Factor-21 (FGF-21) peptide conjugate comprising:
- i) a mutant FGF-21 peptide comprising the amino acid sequence of SEQ ID NO:
- 2,
- ii) a glycosyl moiety, and
- iii) a 20 kDa polyethylene glycol (PEG),
- wherein the mutant FGF-21 peptide is attached to the glycosyl moiety by a covalent bond between a threonine at amino acid position 173 of SEQ ID NO:
- 2 and a first site of the glycosyl moiety and wherein the glycosyl moiety is attached to the 20 kDa PEG by a covalent bond between a second site of the glycosyl moiety and the 20 kDa PEG;
- (b) 150 mM arginine HCl;
- (c) 0.02% (w/v) Polysorbate 80 (PS-80);
- (d) 20 mM Tris buffer, wherein pH is 7.5;
- and
- (e) a pharmaceutically acceptable carrier,
- wherein the liquid pharmaceutical composition is stable at a temperature of 2° C. to 8° C. for 12 months or more.
10 more elements
A liquid pharmaceutical composition comprising a mutant Fibroblast Growth Factor-21 (FGF-21) peptide conjugate, the mutant FGF-21 peptide comprising:
- i) a mutant FGF-21 peptide comprising the amino acid sequence of SEQ ID NO:
- 2,
- ii) a glycosyl moiety, and
- iii) a 20 kDa polyethylene glycol (PEG),
- wherein the mutant FGF-21 peptide is attached to the glycosyl moiety by a covalent bond between a threonine at amino acid position 173 of SEQ ID NO:
- 2 and a first site of the glycosyl moiety and wherein the glycosyl moiety is attached to the 20 kDa PEG by a covalent bond between a second site of the glycosyl moiety and the 20 kDa PEG;
- wherein the liquid pharmaceutical composition comprises 20 mg/mL mutant FGF-21 peptide conjugate, 150 mM arginine HCl, 20 mM Tris, 0.02% (w/v) PS-80 and wherein pH is 7.5,
- wherein the liquid pharmaceutical composition is stable at a temperature of 2° C. to 8° C. for 12 months or more.
5 more elements
Dependencies are inferred from the claim text.