JPWO2020033872A5 - - Google Patents

Claims (13)

1. A pharmaceutical composition for use in a method of treating knee and/or hip pain in a subject having knee and/or hip osteoarthritis, wherein said subject is unresponsive to analgesic treatment, or suffer side effects of analgesic treatment,
The pharmaceutical composition comprises a therapeutically effective amount of an anti-NGF antibody or antigen-binding fragment thereof that specifically binds nerve growth factor (NGF), wherein the antibody or antigen-binding fragment thereof comprises SEQ ID NOS: 4, 6, and 8 (HCDR1, HCDR2, and HCDR3), and three light chain complementarity determining region (LCDR) sequences, including SEQ ID NOs: 12, 14, and 16, respectively. (LCDR1, LCDR2, and LCDR3);
The method comprises administering to the subject a dose of 1 mg to less than 6 mg of the antibody or antigen-binding fragment thereof;
administration of the pharmaceutical composition reduces knee or hip pain in the subject;
Said pharmaceutical composition. 2. The pharmaceutical composition of Claim 1, wherein the analgesic treatment is selected from the group consisting of acetaminophen, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and combinations thereof. 3. The pharmaceutical composition of claim 1 or 2, wherein each dose of the pharmaceutical composition comprises 1 mg or 3 mg of anti-NGF antibody or antigen-binding fragment thereof. 1. A pharmaceutical composition for reducing the risk of arthritis associated with treatment with an anti-nerve growth factor (NGF) antibody in a subject with knee and/or hip osteoarthritis, said pharmaceutical composition comprising: An anti-NGF antibody or antigen-binding fragment thereof that specifically binds nerve growth factor (NGF), wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determinations comprising SEQ ID NOS: 4, 6, and 8, respectively a region (HCDR) sequence (HCDR1, HCDR2, and HCDR3) and three light chain complementarity determining region (LCDR) sequences (LCDR1, LCDR2, and LCDR3) comprising SEQ ID NOs: 12, 14, and 16, respectively;
the antibody or antigen-binding fragment thereof is administered to the subject at a dose of 1 mg to less than 6 mg;
Said pharmaceutical composition. 5. The pharmaceutical composition of claim 4, wherein each dose of said pharmaceutical composition comprises an amount selected from the group consisting of 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg of anti-NGF antibody or antigen-binding fragment thereof. 6. The pharmaceutical composition according to claim 4 or 5, wherein arthrosis comprises rapidly progressive osteoarthritis. 7. The pharmaceutical composition according to any one of claims 1-6, formulated for subcutaneous administration. 7. The pharmaceutical composition according to any one of claims 1 to 6, for administration once every four weeks. 9. The pharmaceutical composition of any one of claims 1-8, wherein the anti-NGF antibody or antigen-binding fragment thereof is administered to the subject at a dose of 1 mg every 4 weeks or every 8 weeks. Subjects were diagnosed as having moderate to severe pain in the index joint at the knee and/or hip, defined as a Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain subscale score of 4 or greater. 10. The pharmaceutical composition of any one of claims 1-9, wherein 11. The pharmaceutical composition of any one of claims 1-10, wherein the subject has a Kellgren-Lawrence [KL] rating of 2 or greater on a scale of 0-4 prior to initiation of treatment. 12. The anti-NGF antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:2 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:10. The pharmaceutical composition according to any one of 13. The pharmaceutical composition of any one of claims 1-12, wherein the antibody is fasinumab.