US 12,404,334 B2
Methods of treating gastrointestinal inflammatory disease
Peter Evan Harwin, Dorado, PR (US); Tomas Kiselak, Dorado, PR (US); Hussam Hisham Shaheen, Auburn, NH (US); and Eric Franklin Zhu, Cambridge, MA (US)
Assigned to Paragon Therapeutics, Inc., Waltham, MA (US)
Filed by Paragon Therapeutics, Inc., Waltham, MA (US)
Filed on Apr. 17, 2025, as Appl. No. 19/182,382.
Application 19/182,382 is a continuation of application No. 18/774,123, filed on Jul. 16, 2024, granted, now 12,304,956.
Application 18/774,123 is a continuation of application No. PCT/US2024/031569, filed on May 30, 2024.
Claims priority of provisional application 63/559,081, filed on Feb. 28, 2024.
Claims priority of provisional application 63/554,886, filed on Feb. 16, 2024.
Claims priority of provisional application 63/599,922, filed on Nov. 16, 2023.
Claims priority of provisional application 63/505,962, filed on Jun. 2, 2023.
Claims priority of provisional application 63/504,966, filed on May 30, 2023.
Prior Publication US 2025/0243280 A1, Jul. 31, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 16/28 (2006.01); A61K 9/00 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61P 1/00 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/2839 (2013.01) [A61K 9/0019 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61P 1/00 (2018.01); A61K 2039/505 (2013.01); A61K 2039/545 (2013.01)] 20 Claims
 
1. A method of treating a gastrointestinal inflammatory disease in a subject in need thereof, the method comprising:
administering to the subject in need thereof two or more doses of a citrate-free pharmaceutical composition, wherein the citrate-free pharmaceutical composition comprises from about 150 mg/ml to about 200 mg/ml of a long acting α4β7 targeting molecule, wherein the two or more doses are administered at least eight weeks apart, and
wherein the long acting α4β7 targeting molecule comprises:
(i) a heavy chain consisting of an amino acid sequence according to SEQ ID NO: 1; and
(ii) a light chain consisting of an amino acid sequence according to SEQ ID NO: 3.