Methods for the treatment of gpp

Patent metadata

Field	Value
Publication number	US-2024352137-A1
Application number	US-202418755744-A
Country	US
Kind code	A1
Filing date	Jun 27, 2024
Priority date	Mar 4, 2021
Publication date	Oct 24, 2024
Grant date	—

Abstract

The present invention relates to the treatment of or alleviation of signs and symptoms of GPP or an acute phase flare-up of generalized pustular psoriasis (GPP) with anti-interleukin-36R (anti-IL36R) antibodies.

First claim

1 . A method of treating generalized pustular psoriasis (GPP) flares in a patient, comprising administering to the patient two 900 mg intravenous (i.v.) doses of an anti-IL-36R antibody, wherein the anti-IL-36R antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO: 80; and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 89; wherein the second dose is administered after 1 week but less than 2 weeks from the first dose.

2 . The method according to claim 1 , wherein the anti-IL-36R antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO: 118; and a heavy chain comprising the amino acid sequence of SEQ ID NO: 127.

3 . The method according to claim 1 , wherein the anti-IL-36R antibody is spesolimab.

4 . The method according to claim 1 , wherein the patient has a GPP Physician Global Assessment (GPPGA) total score of ≥2.

5 . The method according to claim 1 , wherein the patient has a GPP Physician Global Assessment (GPPGA) total score of ≥2 and a GPPGA pustulation subscore of ≥2.

6 . The method according claim 1 , wherein the patient has a GPP Physician Global Assessment (GPPGA) total score of ≥2 and a GPPGA pustulation subscore of ≥2 before the administration of the first i.v. dose.

7 . The method according to claim 1 , wherein the patient has a GPP Physician Global Assessment (GPPGA) total score of ≥2 and a GPPGA pustulation subscore of ≥2 after the administration of the first i.v. dose.

8 . The method according to claim 1 , wherein the patient has a GPP Physician Global Assessment (GPPGA) total score of ≥2 and a GPPGA pustulation subscore of ≥2 before and after the administration of the first i.v. dose.

9 . The method according to claim 1 , wherein the two-dose administration achieves one or more of the following results in: (a) a Generalized Pustular Psoriasis Global Assessment (GPPGA) pustulation subscore of 0 indicating in one week after administering the second i.v. dose; (b) a GPPGA total score of 0 or 1 in one week after administering the second i.v. dose; and/or (c) a lower maximum ADA titer at 2, 4, 6, 8, 10 or 12 weeks after administering the second i.v. dose.

10 . The method according to claim 9 , wherein the results are maintained for up to and at least 12 weeks following the administration of the second i.v. dose.

11 . The method according to claim 1 , wherein the method further comprises administering to the patient a prophylactically effective amount of the anti-IL-36R antibody in one or more subcutaneous doses after the last i.v. dose administered.

12 . The method according to claim 11 , wherein each of the one or more subcutaneous doses comprises 150 mg, 225 mg, 300 mg, 450 mg, or 600 mg of said anti-IL-36R antibody.

13 . The method according to claim 12 , wherein 1, 2, 3 or more subcutaneous doses are administered to the patient and wherein a first subcutaneous dose is administered after the last intravenous dose.

14 . The method according to claim 13 , wherein a first subcutaneous dose is administered 2 to 8 weeks, 4 to 6 weeks, 2 weeks, 4 weeks, 6 weeks or 8 weeks, 12 weeks, 16 weeks, 20 weeks after the last intravenous dose, and subsequent subcutaneous doses are administered at 2, 4, 6-, 8-, 10-, or 12-weeks intervals after the first subcutaneous dose.

15 . The method according to claim 1 , wherein the patient remains in clinical remission as measured by a GPPGA total score of 0 or 1 for at least 12, 24, 36, 48, 60 or 72 weeks following the last i.v. or subcutaneous dose.

Assignees

• Boehringer Ingelheim Int

Inventors

• Hall David B
• Lang Benjamin
• Thoma Christian

Classifications

• C07K2317/734

  Complement-dependent cytotoxicity [CDC] · CPC title

• C07K2317/732

  Antibody-dependent cellular cytotoxicity [ADCC] · CPC title

• C07K2317/73

  Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K2317/54

  F(ab')2 · CPC title