IL-17 receptor antibody formulation
View Patent ↗The present disclosure relates to AM-14 pharmaceutical formulations and therapeutic dosing regimens for the treatment of disease.
1. A pharmaceutical formulation, comprising an aqueous solution of a glutamic acid buffer and an antibody or a fragment thereof comprising a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, wherein said antibody, or fragment thereof, specifically binds human IL-17 receptor A, and wherein:
a) said formulation has a glutamic acid concentration of 10±0.2 mM;
b) said formulation has a pH of 4.8±0.2;
c) said formulation further comprises 3±0.2% proline (w/v) and 0.01±0.002% (w/v) polysorbate 20;
d) said antibody is at a concentration of about 140±5% mg/ml; and
e) said formulation has a viscosity of 5 to 7 cP at 25 degrees C.
2. The pharmaceutical formulation of claim 1 , wherein the antibody or fragment thereof comprises a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO:3 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO:4.
3. The pharmaceutical formulation of claim 1 , wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:1 or 12 and a light chain comprising the amino acid sequence of SEQ ID NO:2.
4. The pharmaceutical formulation of claim 1 , having an osmolarity of 275 to 325 osm.
5. A pharmaceutical container, containing a vessel and the pharmaceutical formulation of any of claims 1 to 4 , wherein the vessel is a vial, bottle, pre-filled syringe, or pre-filled autoinjector syringe.
6. A kit, comprising one or more pharmaceutical containers according to claim 5 and instructions regarding the use thereof.