Romosozumab

Romosozumab
Monoclonal antibody
Type Whole antibody
Source Humanized (from mouse)
Target Sclerostin
Clinical data
Legal status
  • Investigational
Identifiers
CAS Number 909395-70-6 N
ATC code None
ChemSpider none
KEGG D10156 N
Chemical data
Formula C6452H9926N1714O2040S54
Molar mass 145.9 kg/mol
 NYesY (what is this?)  (verify)

Romosozumab (AMG 785) is a humanized monoclonal antibody that targets sclerostin for the treatment of osteoporosis.[1]

Romosozumab was originally discovered by Celltech (now owned by UCB).[2] Celltech entered in a partnership with Amgen in 2002 for the product's development.[3]

Romosozumab is of interest because of sclerostin's specificity to bone.[4] Its use has increased bone growth in preclinical trials in osteoporotic rats and monkeys.[5][6] In a Phase I study, a single dose of Romosozumab increased bone density in the hip and spine in healthy men and postmenopausal women and the drug was well tolerated.[7] In a Phase II trial, one year of Romosozumab treatment in osteoporotic women increased bone density more than bisphosphonate and teriparatide treatment; it had mild injection side effects.[8][9]

As of January 2014, Phase 3 clinical trials are recruiting patients.[10]

References

  1. ↑ "Statement On A Nonproprietary Name Adopted By The USAN Council: Romosozumab" (PDF). American Medical Association.
  2. ↑ Osteocyte control of bone formation via sclerostin, a novel BMP antagonist. EMBO J. 2003 Dec 1;22(23):6267-76.
  3. ↑ Celltech group Annual Report and Accounts 2002
  4. ↑ Bonewald LF (February 2011). "The amazing osteocyte". J. Bone Miner. Res. 26 (2): 229–38. doi:10.1002/jbmr.320. PMC 3179345. PMID 21254230.
  5. ↑ Li, X.; Ominsky, M. S.; Warmington, K. S.; Morony, S.; Gong, J.; Cao, J.; Gao, Y.; Shalhoub, V.; Tipton, B.; Haldankar, R.; Chen, Q.; Winters, A.; Boone, T.; Geng, Z.; Niu, Q. T.; Ke, H. Z.; Kostenuik, P. J.; Simonet, W. S.; Lacey, D. L.; Paszty, C. (2009). "Sclerostin Antibody Treatment Increases Bone Formation, Bone Mass, and Bone Strength in a Rat Model of Postmenopausal Osteoporosis*". Journal of Bone and Mineral Research 24 (4): 578–588. doi:10.1359/jbmr.081206. PMID 19049336.
  6. ↑ Ominsky, M. S.; Vlasseros, F.; Jolette, J.; Smith, S. Y.; Stouch, B.; Doellgast, G.; Gong, J.; Gao, Y.; Cao, J.; Graham, K.; Tipton, B.; Cai, J.; Deshpande, R.; Zhou, L.; Hale, M. D.; Lightwood, D. J.; Henry, A. J.; Popplewell, A. G.; Moore, A. R.; Robinson, M. K.; Lacey, D. L.; Simonet, W. S.; Paszty, C. (2010). "Two doses of sclerostin antibody in cynomolgus monkeys increases bone formation, bone mineral density, and bone strength". Journal of Bone and Mineral Research 25 (5): 948–959. doi:10.1002/jbmr.14. PMID 20200929.
  7. ↑ Padhi, D.; Jang, G.; Stouch, B.; Fang, L.; Posvar, E. (2011). "Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody". Journal of Bone and Mineral Research 26 (1): 19–26. doi:10.1002/jbmr.173. PMID 20593411.
  8. ↑ Burgers TA, Williams BO (June 2013). "Regulation of Wnt/β-catenin signaling within and from osteocytes". Bone 54 (2): 244–9. doi:10.1016/j.bone.2013.02.022. PMID 23470835.
  9. ↑ Reid, I. R. (2012). "Osteoporosis treatment at ASBMR 2012". IBMS BoneKEy 9. doi:10.1038/bonekey.2012.245.
  10. ↑ ClinicalTrials.gov: Romosozumab


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