Method of treating inflammatory bowel disease

1 . A method of treating inflammatory bowel disease in a subject in need thereof, the method comprising:

(a) administering to the subject in need thereof an induction dose comprising from about 300 mg to about 1200 mg of a long acting α4β7 targeting molecule in a single injection or multiple injections;

(b) administering subcutaneously to the subject in need thereof a first maintenance dose comprising from about 300 mg to about 450 mg of the long acting α4β7 targeting molecule,

wherein the first maintenance dose is administered at least two weeks after administering the induction dose; and

(c) administering subcutaneously to the subject in need thereof a second maintenance dose comprising from about 300 mg to about 450 mg of the long acting α4β7 targeting molecule to treat the subject in need thereof,

wherein the induction dose comprises a same or higher amount of the long acting α4β7 targeting molecule than the first and the second maintenance doses,

wherein the first and second maintenance doses comprise the long acting α4β7 targeting molecule at a concentration of at least 180 mg/mL, and wherein the first and second maintenance doses are administered at least twelve weeks apart,

wherein the long acting α4β7 targeting molecule comprises:

a heavy chain consisting of an amino acid sequence according to SEQ ID NO: 1; and

a light chain consisting of an amino acid sequence according to SEQ ID NO: 3.

2 . The method of claim 1 , comprising administering subcutaneously to the subject in need thereof from about 300 mg to about 450 mg of one or more maintenance doses, wherein each of the one or more maintenance doses comprise the long acting α4β7 targeting molecule at a concentration of at least 180 mg/mL, and wherein consecutive maintenance doses are administered at least twelve weeks apart.

3 . The method of claim 1 , comprising administering the induction dose intravenously.

4 . The method of claim 1 , comprising administering the induction dose subcutaneously.

5 . The method of claim 1 , wherein the inflammatory bowel disease is Crohn's disease.

6 . The method of claim 1 , wherein the inflammatory bowel disease is ulcerative colitis.

7 . The method of claim 1 , wherein each of the maintenance doses of the long acting a 487 targeting molecule comprises about 300 mg of the long acting a 487 targeting molecule.

8 . The method of claim 1 , wherein the induction dose of the long acting α4β7 targeting molecule comprises about 600 mg of the long acting α4β7 targeting molecule.

9 . The method of claim 1 , wherein the induction dose of the long acting α4β7 targeting molecule comprises about 1000 mg of the long acting α4β7 targeting molecule.

10 . The method of claim 1 , wherein the induction dose is administered subcutaneously.

11 . The method of claim 1 , wherein the induction dose is administered intravenously.

12 . The method of claim 1 , wherein the first and second maintenance doses are administered subcutaneously about 12 to about 13 weeks apart.

13 . The method of claim 1 , wherein the first and second maintenance doses are administered subcutaneously about 24 to about 26 weeks apart.

14 . The method of claim 1 , wherein an amount of the induction dose is about 2 or more times higher than an amount of each of the maintenance doses.

15 . The method of claim 1 , wherein:

(a) the long acting α4β7 targeting molecule follows a biphasic decline in serum concentration,

(b) repeated dosing of the long acting α4β7 targeting molecule does not have a significant influence on clearance (CL) and steady-state volume of distribution (Vss),

(c) pharmacokinetics are not impacted by disease state of the subject, or

(d) a combination thereof.

16 . The method of claim 1 , resulting in at least one of the following:

(a) a serum C avgWO-W12 of from 60 μg/ml to 70 μg/ml or greater, (b) a serum C avgWo-W6 of from 65 μg/ml to 75 μg/ml or greater, (c) a serum C avgW30-W40 of 30 μg/ml or greater, (d) a serum C avg of from 40 μg/ml to 50 μg/ml or greater following administration of the first and second maintenance doses, (e) a serum Ctrough of 35 μg/ml or greater six weeks following administration of the induction dose, (f) a steady state serum C trough of 6 μg/ml or greater following administration of the first and second maintenance doses.

17 . The method of claim 1 , wherein the administering results in a serum C avgWO-W12 of about 65 μg/ml.

18 . The method of claim 1 , wherein the administering results in a serum C avgWO-W6 of about 70 μg/ml.

19 . The method of claim 1 , wherein the administering results in a serum C avgWO-W6 of about 65 μg/ml.

20 . The method of claim 1 , wherein the administering results in a serum C avg of about 45 μg/ml.

21 . The method of claim 1 , resulting in an average serum concentration of the long acting α4β7 targeting molecule above 35 μg/ml for ten weeks following administration of the first and second maintenance doses.

22 . A method of treating inflammatory bowel disease in a subject in need thereof, the method comprising:

(a) administering subcutaneously to the subject in need thereof an induction dose comprising about 600 mg of a long acting α4β7 targeting molecule; and

(b) administering subcutaneously to the subject in need thereof at least a first and a second maintenance doses of the long acting α4β7 targeting molecule, each of the at least first and second maintenance doses comprising about 300 mg of the long acting α4β7 targeting molecule to treat the subject in need thereof,

wherein the first maintenance dose is administered at least two weeks after administering the induction dose,

wherein the at least first and second maintenance doses comprise the long acting α4β7 targeting molecule at a concentration of at least 180 mg/mL, and are administered at least twelve weeks apart,

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.