IL-17 receptor antibody formulation
The present disclosure relates to AM-14 pharmaceutical formulations and therapeutic dosing regimens for the treatment of disease.
1. A pharmaceutical formulation comprising:
(i) 140 mg/mL of an antibody, or antigen-binding fragment thereof, that specifically binds human IL-17 receptor A,
(ii) 30 mM glutamic acid,
(iii) a pH of 4.55-4.93,
(iv) 2-4% (w/v) proline, and
(v) 0.01±0.002% (w/v) polysorbate 20, wherein
the antibody comprises a heavy chain CDR1 comprising the amino acid sequence of SEQ ID NO:5, a heavy chain CDR2 comprising the amino acid sequence of SEQ ID NO:7, a heavy chain CDR3 comprising the amino acid sequence of SEQ ID NO:8, a light chain CDR1 comprising the amino acid sequence of SEQ ID NO:9, a light chain CDR2 comprising the amino acid sequence of SEQ ID NO: 10, and a light chain CDR3 comprising the amino acid sequence of SEQ ID NO: 11.
2. The pharmaceutical formulation of claim 1 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable domain comprising the amino acid sequence comprising SEQ ID NO:3 and a light chain variable domain comprising the amino acid sequence comprising SEQ ID NO:4.
3. The pharmaceutical formulation of claim 1 , wherein the antibody comprises a heavy chain amino acid sequence comprising SEQ ID NO:1 or SEQ ID NO: 12 and a light chain amino acid sequence comprising SEQ ID NO:2.
4. The pharmaceutical formulation of claim 1 , which comprises an osmolarity of 250 to 400 mOsm/L.
5. The pharmaceutical formulation of claim 1 , which comprises a viscosity of 5 to 7 cP at 25° C.
6. A kit comprising the pharmaceutical formulation of claim 1 and instructions regarding the use thereof.