Compositions and methods for treating immune thrombocytopenia

12202,900

16/435166

June 07, 2019

A method is disclosed for the treatment of human subjects diagnosed with immune thrombocytopenia (ITP). The method comprises administering to a human subject a human neonatal Fc receptor (hFcRn) antagonist, optionally in combination with standard-of-care ITP treatment. In certain embodiments, the hFcRn antagonist is efgartigimod (ARGX-113). Standard-of-care ITP treatment may comprise administration of corticosteroids, immunosuppressants, and/or thrombopoietin receptor (TPO-R) agonists.

argenx BV (Ghent, BE)

argenx BV (Ghent, BE)

1. A method of treating a human subject that has newly diagnosed, persistent, or chronic immune thrombocytopenia (ITP), the method comprising administering to the subject a human neonatal Fc receptor (hFcRn) antagonist, wherein the hFcRn antagonist is administered intravenously once weekly at a dose of about 5 mg/kg to about 10 mg/kg at least four times, wherein the hFcRn antagonist consists of a variant Fc region consisting of two Fc domains which form a homodimer, wherein the amino acid sequence of each of the Fc domains consists of SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3, wherein the human subject has a platelet count of ≤30×10 9 /L on standard-of-care treatment with at least one compound approved for standard-of-care treatment for ITP prior to administering the hFcRn antagonist, and wherein the subject achieves a platelet count of >50×10 9 /L after administering four doses of the hFcRn antagonist, thereby treating the subject.

2. The method of claim 1 , wherein the hFcRn antagonist is efgartigimod.

3. The method of claim 2 , wherein the efgartigimod is administered intravenously at a dose dosage of about 5 mg/kg or about 10 mg/kg.

4. The method of claim 1 , wherein the human subject has a platelet count of less than 30×10 9 /L prior to administering the hFcRn antagonist.

5. The method of claim 1 , wherein the human subject receives one or more doses of at least one compound approved for standard-of-care treatment for ITP.

6. The method of claim 1 , wherein the human subject has persistent or chronic ITP.

7. The method of claim 5 , wherein the compound approved for standard-of-care treatment for ITP is selected from the group consisting of corticosteroids, romiplostim, eltrombopag, avatrombopag, cyclosporine, dapsone, danazol, azathioprine, intravenous immunoglobulin (IVIg), Rho(D) immune globulin (anti-D), rituximab, fostamatinib, and alemtuzumab.

8. The method of claim 1 , wherein the human subject has chronic ITP.

9. The method of claim 2 , wherein the efgartigimod is administered intravenously at a dose of about 10 mg/kg.

10. The method of claim 9 , wherein the efgartigimod is administered intravenously at a dose of about 10 mg/kg every two weeks after administering the first four doses.

11. The method of claim 5 , wherein the at least one compound approved for standard-of-care treatment for ITP is administered prior to administering one or more doses of the hFcRn antagonist.

12. The method of claim 7 , wherein the corticosteroid is selected from the group consisting of prednisone, methylprednisolone, and dexamethasone.

13. The method of claim 1 , wherein the human subject achieves a platelet count of >50×10 9 /L for at least 4 weeks.

14. The method of claim 1 , wherein the human subject achieves a platelet count of >50×10 9 /L for at least 4 of 6 consecutive weeks.

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