Granted Patent B2

US 12,226,448 · App. 16/721,805 · Granted Feb 18, 2025

Inventors: John Graham Matthews (San Francisco, CA); Kari Rose Brown (Cary, NC); Anoshie Ratnayake (Newport Beach, CA); Daniel Adelman (Redwood City, CA)

Assignee: Société des Produits Nestlé S.A.

A61K38/168A61K9/0053

Abstract

Claims (42)

1. A method of continuing an oral immunotherapy for the treatment of a peanut allergy in a patient after missing a scheduled administration of one or more consecutive doses of a pharmaceutical composition comprising peanut protein, wherein the patient began an oral immunotherapy and missed one or more doses of the up-dosing phase or the maintenance phase of the oral immunotherapy, the oral immunotherapy comprising:

(i) an up-dosing phase comprising orally administering to the patient a series of escalating doses of the pharmaceutical composition with a single dose administered on a daily basis, wherein the series of escalating doses administered during the up-dosing phase comprises doses of 3 mg to 300 mg peanut protein, and wherein a given dose is administered to the patient for at least a predetermined period of time before the dose is escalated, and

(ii) a maintenance phase comprising orally administering to the patient a plurality of maintenance doses of the pharmaceutical composition after completion of the up-dosing phase, wherein the maintenance dose of the pharmaceutical composition comprise about 300mg peanut protein and are administered daily;

the method comprising:

orally administering to the patient a dose of the pharmaceutical composition after missing the scheduled one or more consecutive doses, wherein:

(1) if one or two consecutive doses are missed, the dose administered to the patient is the same as the most recently administered dose;

(2) if three or four consecutive doses are missed, the dose administered to the patient is reduced compared to the most recently administered dose, wherein the dose is reduced by:

(i) 25% or more, and the dose is administered to the patient under medical supervision, or without medical supervision; or

(ii) 50% or more and the dose is administered under medical supervision, or without medical supervision;

(3) if five to seven consecutive doses are missed during the up-doing phase, the dose administered to the patient is reduced by 50% or more compared to the most recently administered dose;

(4) if eight to fourteen consecutive doses are missed during the up-dosing phase, the dose administered to the patient is reduced by 75% or more compared to the most recently administered dose;

(5) if five to fourteen consecutive doses are missed during the maintenance phase, the dose administered to the patient is 120 mg; and

(6) if more than fourteen consecutive doses are missed, the dose administered to the patient is an initial dose of the up-dosing phase.

2. The method of claim 1 , wherein the missed one or more consecutive doses were scheduled during the up-dosing phase.

3. The method of claim 1 , wherein the missed one or more consecutive doses were scheduled during the maintenance phase.

4. The method of claim 1 , wherein the pharmaceutical composition comprises defatted peanut flour.

5. The method of claim 1 , wherein the series of escalating doses of the pharmaceutical composition administered during the up-dosing phase comprises 5 to 15 different dose levels.

6. The method of claim 1 , wherein the series of escalating doses administered during the up-dosing phase comprises 11 different dose levels.

7. The method of claim 1 , wherein the series of escalating doses administered during the up-dosing phase comprises doses of 3 mg peanut protein, 6 mg peanut protein, 12 mg peanut protein, 20 mg peanut protein, 40 mg peanut protein, 80 mg peanut protein, 120 mg peanut protein, 160 mg peanut protein, 200 mg peanut protein, 240 mg peanut protein, and 300 mg peanut protein.

8. The method of claim 1 , wherein:

(1) if one to two consecutive doses are missed during the up-dosing phase, the dose administered to the patient is the same as the most recently administered dose;

(2) if three or four consecutive doses are missed during the up-dosing phase, the dose administered to the patient is reduced by: (i) 25% or more, or (ii) 50% or more, and the dose is administered to the patient under medical supervision;

(3) if five to seven consecutive doses are missed during the up-dosing phase, the dose administered to the patient is reduced by 50% or more compared to the last administered dose and the dose is administered to the patient under medical supervision;

(4) if eight to fourteen consecutive doses are missed during the up-dosing phase, the dose administered to the patient is reduced by 75% or more compared to the last administered dose and the dose is administered to the patient under medical supervision; and

(5) if more than fourteen consecutive doses are missed during the up-dosing phase, the dose administered to the patient is an initial dose of the up-dosing phase.

9. The method of claim 1 , wherein:

(1) if one to two consecutive doses are missed during the maintenance phase, the dose administered to the patient is the same as the most recently administered dose;

(2) if three or four consecutive doses are missed during the maintenance phase, the dose administered to the patient is reduced by: (i) 25% or more, or (ii) 50% or more, and the dose is administered to the patient under medical supervision;

(3) if five to seven consecutive doses are missed during the maintenance phase, the maintenance phase dosing administered to the patient is 120 mg, and the dose is administered to the patient under medical supervision;

(4) if eight to fourteen consecutive doses are missed during the maintenance phase, the maintenance phase administered to the patient is 120 mg, and the dose is administered to the patient under medical supervision; and

(5) if more than fourteen consecutive doses are missed during the maintenance phase, the maintenance phase dosing is ended and an up-dosing is restarted at an initial dose of the up-dosing phase.

10. The method of claim 1 , wherein the given dose is administered to the patient for at least two weeks of time before the dose is escalated.

11. The method of claim 1 , wherein the patient is 1 year of age or older.

12. The method of claim 1 , wherein the patient is 4 years of age or older.

13. The method of claim 1 , wherein the patient is between 4 years of age and 12 years of age.

14. The method of claim 1 , wherein the patient is between 12 years of age and 18 years of age.

15. The method of claim 1 , wherein the patient is between 18 years of age and 26 years of age.

16. The method of claim 1 , wherein is 26 years of age or older.

17. The method of claim 1 , wherein the oral immunotherapy further comprises an initial escalation phase.

18. The method of claim 17 , where the initial escalation phase comprises a series of escalating doses from 0.5 mg to 6 mg peanut protein.

19. The method of claim 18 , wherein the series of escalating doses administered during the initial escalation phase comprises doses of 0.5 mg peanut protein, 1 mg peanut protein, 1.5 mg peanut protein, 3 mg peanut protein, and 6 mg peanut protein.

20. The method of claim 18 , where the series of escalating doses are administered on the same day and spaced out by 10 minutes to 60 minutes.

Assignments (2)

Continuity (2)

References Cited (279)