Method for the treatment of a relapsing-remitting condition
The present invention relates to a method for the acute treatment of a relapsing-remitting condition, the method comprising the step of administering to a subject in need thereof one or more doses of an effective amount of a peptide molecule as defined in claim 1 in response to or during a relapse, wherein the method causes remission of the condition.
1. A method for the acute treatment of an allergic inflammation, the method comprising the steps of:
(a) administering to a subject in need thereof one or more doses of an effective amount of a peptide molecule comprising or consisting of an amino acid sequence as set forth in SEQ ID NO:1, or having more than 95% identity to the amino acid sequence as set forth in SEQ ID NO:1 in response to or during a relapse, wherein the acute treatment causes remission of the allergic inflammation in the subject, and
(b) stopping the administration of the peptide molecule upon remission of the allergic inflammation.
2. The method of claim 1 , wherein the peptide molecule is less than 50 amino acid residues in length.
3. The method of claim 1 , wherein the peptide molecule is less than 40 amino acid residues in length.
4. The method of claim 1 , wherein the peptide molecule consists of the amino acid sequence of SEQ ID NO:1.
5. The method of claim 1 , wherein the remission comprises reduction, alleviation or elimination of one or more symptoms of atopic dermatitis or allergic skin hypersensitivity.
6. The method of claim 1 , wherein the remission comprises reduction, alleviation or elimination of one or more symptoms of the allergic inflammation for a period of time which significantly exceeds a plasma pharmacokinetic half-life of the peptide molecule.
7. The method of claim 1 , wherein the remission is maintained when a plasma concentration of the peptide molecule is below a lower limit of quantification.
8. The method of claim 7 , wherein the plasma concentration is below the lower limit of quantification at circulating levels of less than 20 ng/mL.
9. The method of claim 7 , wherein the remission of the allergic inflammation is for a period of at least 7 days after the plasma concentration is below the lower limit of quantification.
10. The method of claim 1 , wherein the remission of the allergic inflammation is for a period of at least 7 days after administration of a final dose of the peptide molecule.
11. The method of claim 10 , wherein the remission of the allergic inflammation is for a period of at least 14 days after administration of the final dose of the peptide molecule.
12. The method of claim 11 , wherein the remission of the allergic inflammation is for a period of at least 28 days after administration of the final dose of the peptide molecule.
13. The method of claim 12 , wherein the remission of the allergic inflammation is for a period of at least 6 months after administration of the final dose of the peptide molecule.
14. The method of claim 1 , wherein the remission of the allergic inflammation is maintained without the need for the administration of a further dose of the peptide.
15. The method of claim 1 , wherein the remission comprises a significant change in the amount of one or more inflammatory markers in the subject relative to a control subject.
16. The method of claim 1 , wherein the remission comprises a significant increase in the amount of IL-10 in the subject relative to a control subject.
17. The method of claim 1 , wherein the level of one or more of TNF-alpha, IL-1b, IFN-gamma, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17, IL-23, KC (CCL-1), Eotaxin (CCL-11), TARC (CCL-17) and/or MDC (CCL-22) are decreased following administration of SEQ ID NO:1 as compared to prior to administration.
18. The method of claim 1 , wherein the subject is further administered one or more additional therapeutic agents.
19. The method of claim 18 , wherein the one or more therapeutic agents is selected from the group consisting of disease modifying agents, analgesics, anti-inflammatory agents, anti-allergic drugs, allergen immunotherapeutic agents, antivirals, antibiotics, antibodies and steroids.
20. The method of claim 15 , wherein the one or more inflammatory markers are cytokines.
21. The method of claim 20 , wherein the cytokines are selected from the group consisting of:
IL-4, IL-5, IL-10, and IL-13.