ORAL COMPOSITION OF ANTI-TNF ALPHA ANTIBODIES
The present invention relates to a pharmaceutical composition for oral delivery, including an anti tumour necrosis factor alpha (TNF.alpha.) antibody, preferably a monoclonal antibody produced in the milk of a transgenic non-human animal, and which can be combined advantageously with caprylic acid, and is preferably in a form that is suitable for targeted release of the antibody in the intestine.
1 . A pharmaceutical composition suitable for oral administration, comprising a monoclonal anti-tumor necrosis factor alpha (TNFα) antibody produced in the milk of a transgenic non-human animal.
2 .- 8 . (canceled)
9 . A method for treating an inflammatory disease in a patient, which method comprises orally administering to the patient an anti-TNFα antibody, and orally administering to the patient caprylic acid or a caprylate salt, wherein the inflammatory disease is inflammatory bowel disease, and wherein said antibody is in a pharmaceutical composition formulated for targeted release of the antibody in the intestine of the patient.
10 . (canceled)
11 . The method of claim 9 , where said antibody comprises a light chain amino acid sequence set forth by SEQ ID NO: 1 and/or a heavy chain amino acid sequence set forth by SEQ ID NO: 2.
12 . The method of claim 9 , where said antibody is a monoclonal antibody produced in the milk of a transgenic non-human animal.
13 . The method of claim 9 , the antibody and the caprylic acid or the caprylate salt being intended for separate, simultaneous or sequential administration.
14 . (canceled)
15 . A kit comprising, within the same package:
a first container containing a pharmaceutical composition for oral administration, comprising an anti-TNFα antibody, which is preferably a monoclonal antibody produced in the milk of a transgenic non-human animal, preferably a goat;
a second container containing a pharmaceutical composition for oral administration, comprising caprylic acid or a caprylate salt.
16 . The method according to claim 9 , wherein the inflammatory bowel disease is Crohn's disease.
17 . The method according to claim 9 , wherein the antibody has the same amino acid sequence as adalimumab.
18 . The method according to claim 12 , wherein the transgenic non-human animal is a goat.
19 . The method according to claim 9 , wherein the anti-TNFα antibody is orally administered to the patient at a daily dose of 8 mg to 200 mg.
20 . The method according to claim 19 , wherein the anti-TNFα antibody is orally administered to the patient at a daily dose of 8 mg to 35 mg or 15 mg to 70 mg.
21 . The method according to claim 9 , wherein the inflammatory bowel disease is ulcerative colitis.
22 . The method according to claim 9 , wherein, the antibody and caprylic acid or the caprylate salt are administered to the patient concomitantly.
23 . The method according to claim 22 , wherein, the antibody and caprylic acid or the caprylate salt are combined within a same pharmaceutical composition.
24 . The method according to claim 9 , wherein the antibody is in a pharmaceutical composition formulated in galenic form.
25 . The method of claim 24 , where said antibody comprises a light chain amino acid sequence set forth by SEQ ID NO: 1 and/or a heavy chain amino acid sequence set forth by SEQ ID NO: 2.
26 . The method of claim 24 , where said antibody is a monoclonal antibody produced in the milk of a transgenic non-human animal.
27 . The method of claim 24 , the antibody and the caprylic acid or the caprylate salt being intended for separate, simultaneous or sequential administration.
28 . The method according to claim 24 , wherein the inflammatory bowel disease is Crohn's disease.
29 . The method according to claim 24 , wherein, the antibody and caprylic acid or the caprylate salt are administered to the patient concomitantly.