US 11,850,275 B2
Liquid formulations comprising mutant FGF-21 peptide pegylated conjugates
Boris Schwartsburd, Rehovot (IL); and Shaji Joseph, Sunnyvale, CA (US)
Assigned to 89bio, Inc., San Francisco, CA (US)
Filed by 89BIO, INC., San Francisco, CA (US)
Filed on Feb. 6, 2023, as Appl. No. 18/165,081.
Application 18/165,081 is a continuation of application No. 17/692,024, filed on Mar. 10, 2022, granted, now 11,596,669.
Claims priority of provisional application 63/167,148, filed on Mar. 29, 2021.
Claims priority of provisional application 63/159,717, filed on Mar. 11, 2021.
Prior Publication US 2023/0338471 A1, Oct. 26, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/18 (2006.01); A61K 47/54 (2017.01); A61P 3/10 (2006.01); C07K 14/50 (2006.01); A61K 47/60 (2017.01)
CPC A61K 38/1825 (2013.01) [A61K 47/549 (2017.08); A61K 47/60 (2017.08); A61P 3/10 (2018.01); C07K 14/50 (2013.01)] 20 Claims
 
1. A prefilled syringe or autoinjector comprising a liquid pharmaceutical composition, the liquid pharmaceutical composition comprising:
(a) from 28.8 to 43.2 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) from 160 to 240 mM arginine HCl;
(c) from 0.016 to 0.024% (w/v) Polysorbate 80 (PS-80);
(d) from 16 to 24 mM Tris buffer, wherein pH is from 7 to 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.