US 11,851,483 B2
Anti-sclerostin antibodies and their use to treat bone disorders as part of a regimen
Martyn Kim Robinson, Shaftesbury (GB); Michael Stuart Ominsky, Thousand Oaks, CA (US); Xiaodong Li, Thousand Oaks, CA (US); and Hua Zhu Ke, Berkshire (GB)
Assigned to AMGEN INC., Thousand Oaks, CA (US); and UCB PHARMA S.A., Brussels (BE)
Appl. No. 15/534,635
Filed by AMGEN INC., Thousand Oaks, CA (US); and UCB PHARMA, S.A., Brussels (BE)
PCT Filed Dec. 11, 2015, PCT No. PCT/EP2015/079496
§ 371(c)(1), (2) Date Jun. 9, 2017,
PCT Pub. No. WO2016/092101, PCT Pub. Date Jun. 16, 2016.
Claims priority of provisional application 62/091,155, filed on Dec. 12, 2014.
Prior Publication US 2018/0111986 A1, Apr. 26, 2018
Int. Cl. A61K 39/395 (2006.01); C07K 16/22 (2006.01); A61P 19/08 (2006.01); A61P 19/10 (2006.01); A61K 45/06 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/22 (2013.01) [A61K 39/3955 (2013.01); A61K 45/06 (2013.01); A61P 19/08 (2018.01); A61P 19/10 (2018.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); C07K 2317/76 (2013.01); C07K 2317/90 (2013.01); C07K 2317/94 (2013.01)] 13 Claims
 
1. A method for increasing at least one of bone formation, bone mineral density, bone mineral content, bone mass, bone quality and bone strength in a mammalian subject in need thereof, which method comprises:
(a) administering at least two initial doses of sclerostin antibody to a subject in need of such treatment, wherein the initial doses are administered every month or every four weeks, and wherein the sclerostin antibody comprises a set of 6 CDRs set forth in SEQ ID NOs: 245-247 and SEQ ID NOs: 78-80;
(b) administering further doses of sclerostin antibody to the subject, wherein each of the further doses is at least 210 mg, wherein the further doses are administered once every two months or once every four months, and wherein together (a) and (b) comprise administering a batch of doses comprising at least twelve doses of sclerostin antibody;
(c) allowing a dosing holiday that is at least two times greater than the length of the interval between the doses in (b); and
(d) administering to the subject at least one further dose of sclerostin antibody after the dosing holiday of (c).