Claims for Patent: 9,913,900

Summary for Patent: 9,913,900

Title:	Method of treating alvelor bone loss through the use of anti-sclerostin antibodies
Abstract:	The invention provides a method of treating alveolar bone loss involving administration of a sclerostin inhibitor to a subject in need thereof.
Inventor(s):	Ke; Hua Zhu (Newbury Park, CA), Liu; Min (Thousand Oaks, CA), Giannobile; William V. (Ann Arbor, MI)
Assignee:	AMGEN INC. (Thousand Oaks, CA) THE REGENTS OF THE UNIVERSITY OF MICHIGAN (Ann Arbor, MI)
Application Number:	15/494,121
Patent Claims:	1. A method for increasing alveolar bone height in a subject suffering from alveolar bone loss comprising administering to the subject an anti-sclerostin antibody in an amount effective to decrease the distance between the cement-enamel junction and the alveolar bone crest, at a dose from about 5 mg to about 1,000 mg per week, and wherein the anti-sclerostin antibody comprises a light chain variable region amino acid sequence set forth in SEQ ID NO: 376 and a heavy chain variable region amino acid sequence set forth in SEQ ID NO: 378. 2. The method of claim 1, wherein the distance between the cement-enamel junction and the alveolar bone crest is decreased by at least 10% compared to the pretreatment distance by six weeks after initiation of treatment. 3. The method of claim 1, wherein the alveolar bone height is increased by at least 10% compared to the pre-treatment alveolar bone height by six weeks after initiation of treatment. 4. The method of claim 1, wherein the alveolar bone height of the subject is increased by at least 1 mm compared to pre-treatment alveolar bone height by six weeks after initiation of treatment. 5. The method of claim 1, wherein the alveolar bone density of the subject is increased by at least 10% compared to pre-treatment alveolar bone density by six weeks after initiation of treatment. 6. The method of claim 1, wherein the alveolar bone volume fraction is increased by at least 10% compared to pre-treatment bone volume fraction by six weeks after initiation of treatment. 7. The method of claim 1, wherein the antibody is administered in an amount from about 120-270 mg. 8. The method of claim 1, wherein the anti-sclerostin antibody is administered twice a week. 9. The method of claim 1, wherein the anti-sclerostin antibody is administered locally to diseased gingival area or diseased periodontal pocket of the subject. 10. The method of claim 1, wherein the method comprises administering a standard of care therapeutic selected from the group consisting of doxycycline hyclate (Periostat.RTM.) or chemically modified tetracycline-3 (CMT-3) prior to administering the anti-sclerostin antibody. 11. The method of claim 1, further comprising administering a second bone-enhancing therapeutic selected from the group consisting of parathyroid hormone, teriparatide, a bisphosphonate, a receptor activator of nuclear factor kappa-B ligand (RANKL) antibody and a dickkopf-1 (DKK-1) antibody. 12. The method of claim 11, wherein the second bone-enhancing therapeutic is administered after the treatment period with the anti-sclerostin antibody has ended. 13. The method of claim 1, optionally comprising administering the anti-sclerostin antibody for a second period of time in an amount sufficient to maintain alveolar bone. 14. The method of claim 1, wherein the anti-sclerostin antibody is an immunoglobulin comprising a heavy chain and a light chain. 15. The method of claim 1, wherein the anti-sclerostin antibody is an antibody or fragment thereof that demonstrates a binding affinity for sclerostin of SEQ ID NO: 1 of less than or equal to 1.times.10.sup.-9 M. 16. The method of claim 1, wherein the anti-sclerostin antibody neutralizes human sclerostin in a MC3T3 cell-based mineralization assay when there is less than a six-fold excess of moles of sclerostin binding sites per well as compared to the number of moles of sclerostin per well.

Details for Patent 9,913,900

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2031-12-28