ORAL COMPOSITION OF ANTI-TNF ALPHA ANTIBODIES

• US 20170121402A1
• Filed: 06/18/2015
• Published: 05/04/2017
• Est. Priority Date: 06/18/2014
• Status: Abandoned Application

• Current Assignee: Laboratoire francais du Fractionnement et des Biotechnologies
• Original Assignee: Laboratoire francais du Fractionnement et des Biotechnologies
• Inventors: Chtourou, Abdessatar Sami
• Application Number:
  US15/319,178
• Publication Number:
  US 20170121402A1
• Time in Patent Office: Days
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/20 having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/241 Tumor Necrosis Factors
• CPC Class Codes: C07K 2317/12 isolated from milk
• CPC Class Codes: C07K 2317/21 from primates, e.g. man

Abstract

The present invention relates to a pharmaceutical composition for oral delivery, including an anti tumour necrosis factor alpha (TNFα) 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.

Claims

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. The pharmaceutical composition according to claim 1, the composition being in a form suitable for targeted release of the antibody in the intestine.

3. The pharmaceutical composition according to claim 1, wherein the anti-TNFα

antibody is adalimumab or has the protein sequence of adalimumab.

4. The pharmaceutical composition according to claim 1, wherein the transgenic non-human animal is a goat.

5. The pharmaceutical composition according to claim 1, further comprising caprylic acid or a caprylate salt.

6. A method for treating an inflammatory disease in a patient, which method comprises administering to said patient 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.

7. The method according to claim 6, wherein the inflammatory disease is inflammatory bowel disease, such as Crohn’

s disease.

8. The method according to claim 6 wherein the pharmaceutical composition is administered orally at a daily dose of 8 to 200 mg, preferably 8 to 35 or 15 to 70 mg of anti-TNFα

antibody.

9. A method for treating an inflammatory disease in a patient, which method comprises orally administering to the patient an anti-TNFα

antibody, in combination with preferably oral administration of caprylic acid or a caprylate salt.

10. The method according to claim 9, wherein the inflammatory disease is inflammatory bowel disease, preferably Crohn'"'"'s disease.

11. The method according to claim 9, wherein said antibody is adalimumab or has the protein sequence of adalimumab.

12. The method according to claim 9, wherein said antibody is a monoclonal antibody produced in the milk of a transgenic non-human animal, preferably a goat.

13. The method according to claim 9, wherein, the antibody and the caprylic acid or the caprylate salt are administered separately, simultaneously or sequentially.

14. The method according to claim 9, wherein said antibody is in a form suitable for targeted release of the antibody in the intestine.

15. 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.