RU-2026112754-A - Treatment methods for cardiovascular disease

Inventors

• КУЛКAРНИ, Сандип
• Чиунг, Юнг
• ДЖОУНС, Сьюзан Дана
• Ярробино, Райан
• МИДДЛКОФФ, У. Брэдфорд

Assignees

• ТУРМАЛИН БАЙО, ИНК.

Dates

Publication Date

20260505

Application Date

20240927

Priority Date

20240328

Claims (20)

1. 1. A method for treating a patient at risk of developing atherosclerotic cardiovascular disease (ASCVD), comprising administering to the patient a therapeutically effective dose of an antibody or fragment of an antibody to interleukin-6 (antibody to IL-6) comprising the CDRs of the variable region of the heavy chain (VH) defined by SEQ ID NOs: 2, 3 and 4, and the CDRs of the variable region of the light chain (VL) defined by SEQ ID NOs: 8, 9 and 10, wherein the therapeutically effective dose is about 15, about 25 or about 50 mg.
2. 2. The method of claim 1, wherein the treatment is administered to patients at high risk of ASCVD in a primary prevention setting aged 50 years or older with hsCRP greater than or equal to 3 mg/L and with diagnosed diabetes mellitus or 2 or more of the following risk factors: tobacco use, hyperlipidemia, or hypertension, except for patients with a concomitant diagnosed inflammatory or infectious disease.
3. 3. The method of claim 1, wherein the treatment is administered to patients with ASCVD in secondary prevention conditions aged 50 years or older and with hsCRP greater than or equal to 2 mg/L, except for patients in secondary prevention conditions with a concomitant diagnosed inflammatory or infectious disease.
4. 4. The method of claim 1, wherein the method comprises monitoring the patient for safety for 365 days, preferably at 240 days, 300 days, and 365 days.
5. 5. The method according to claims 1-4, wherein the antibody or antibody fragment comprises a heavy chain polypeptide comprising a polypeptide characterized by at least 98% identity with SEQ ID NO: 1, and a light chain polypeptide comprising a polypeptide characterized by at least 98% identity with SEQ ID NO: 7.
6. 6. The method according to claim 5, wherein the antibody or antibody fragment comprises a heavy chain polypeptide having the sequence of SEQ ID NO: 1 and a light chain polypeptide having the sequence of SEQ ID NO: 7.
7. 7. The method according to any one of paragraphs 1-6, further comprising:
8. a) administering to the patient a loading dose of an antibody or antibody fragment to IL-6 during at least the first two doses of the loading regimen and
9. b) subsequent administration to the patient of a maintenance dose of the antibody or antibody fragment to IL-6 during the maintenance regimen.
10. 8. The method of claim 7, wherein the loading regimen comprises administering a loading dose every 1 week, every 2 weeks, or every 4 weeks.
11. 9. The method of claim 7, wherein the maintenance regimen comprises administering a maintenance dose every 4 weeks, every 8 weeks, every 12 weeks, or every 24 weeks.
12. 10. The method according to paragraph 7, further comprising
13. (a) administering to the patient a loading dose of an antibody or antibody fragment to IL-6 every 4 weeks for the first two doses of the loading regimen and
14. (b) subsequent administration to the patient of a maintenance dose of the antibody or antibody fragment to IL-6 every 8 or 12 weeks during the maintenance regimen.
15. 11. The method according to any one of claims 7-10, wherein the loading dose is greater than or equal to the maintenance dose.
16. 12. The method according to any one of paragraphs 1-11, wherein the patient has inflammation.
17. 13. The method of claim 12, wherein the patient has IL-6-mediated inflammation.
18. 14. The method of claim 12 or 13, wherein the treatment is sufficient to reduce inflammation without causing immunosuppression.
19. 15. The method of claim 12, wherein immunosuppression is measured by absolute neutrophil count (ANC).
20. 16. The method of claim 15, wherein the ANC after treatment is at least 500, 1000, 1500, or 2000 cells/pl.