Granted Patent
B2
US 12,433,945 · App. 16/542,198 · Granted Oct 7, 2025
Peanut oral immunotherapy with maintenance dose
Assignee:
Société Des Produits Nestlé S.A.
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Abstract
The present disclosure relates to improved oral immunotherapy methods for treating peanut allergy. The disclosure provides methods for treating a subject for a peanut allergy by an oral immunotherapy comprising an up-dosing phase and a maintenance phase. In certain embodiments, the methods comprise non-daily administration to the subject of a maintenance phase dose. In certain embodiments, the methods comprise administering a maintenance phase dose for more than 24 weeks. In other embodiments, the disclosure provides methods for reducing the risk of an allergic adverse event in a subject receiving an oral immunotherapy dosage therapy.
Claims (19)
1. A method of treating a subject for a peanut allergy by an oral immunotherapy comprising an up-dosing phase and a maintenance phase, the method comprising:
(a) administering to the subject the up-dosing phase;
(b) administering to the subject a maintenance phase dose for more than 24 weeks;
(c) testing the subject for a highest tolerated peanut protein dose by an oral food challenge;
(d) selecting a subject for additional maintenance phase dosing based on the subject tolerating a maximum dose of less than 1,000 mg peanut protein; and
(e) continuing to administer to the selected subject the maintenance phase dose; wherein the maintenance phase dose comprises 300 mg of peanut protein.
2. The method of claim 1 , wherein the maintenance phase dose is administered to the selected subject for at least 4 additional weeks.
3. The method of claim 1 , wherein the selecting a subject for additional maintenance phase dosing is further based on the subject tolerating a cumulative dose of less than 4,043 mg of peanut protein.
4. The method of claim 1 , wherein the maintenance phase dose comprises 300 mg or more of peanut protein.
5. The method of claim 1 , wherein the subject is 12 months old or older.
6. The method of claim 1 , wherein the subject is 4 years old or older.
7. The method of claim 1 , wherein the subject is between 4 years old and 17 years old.
8. The method of claim 1 , wherein the maintenance phase dose is administered to the selected subject for at least 28 additional weeks.
9. The method of claim 1 , wherein the maintenance phase dose is administered to the selected subject for 28 additional weeks to 84 additional weeks.
10. The method of claim 1 , wherein the selected subject tolerates a dose of 2,000 mg peanut protein at completion of the additional weeks of maintenance phase dosing.
11. The method of claim 1 , wherein the selected subject tolerates a cumulative dose of 4,043 mg peanut protein at the completion of the additional weeks of maintenance phase dosing.
12. The method of claim 1 , wherein the up-dosing phase comprises administering to the subject two or more different doses between 3 mg and the dose of the initial maintenance phase dose.
13. The method of claim 1 , wherein the up-dosing phase is between 3 months and 2 years in length.
14. The method of claim 1 , wherein the oral immunotherapy further comprises an initial escalation phase.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 21, 2022
From: AIMMUNE THERAPEUTICS, INC.
To: SOCIÉTÉ DES PRODUITS NESTLÉ S.A.
Reel/Frame 059057/0590 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 13, 2020
From: ADELMAN, DANIEL
To: AIMMUNE THERAPEUTICS, INC.
Reel/Frame 053492/0387 →
Continuity (3)
Provisional Application
62809236
· Feb 22, 2019
Provisional Application
62765123
· Aug 16, 2018
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