Clazakizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | IL6 |
| Clinical data | |
| Routes of administration | infusion |
| ATC code |
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| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number | |
| ChemSpider |
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| Chemical and physical data | |
| Formula | C6426H9972N1724O2032S42 |
| Molar mass | 145.2 kg/mol g·mol−1 |
Clazakizumab (formerly ALD518 and BMS-945429)[1] is an aglycosylated, humanized monoclonal antibody against interleukin-6.[2] It is an investigational drug for cancer and rheumatoid arthritis due to its anti-inflammatory properties. The relatively long half-life of about 30 days should allow less frequent and subcutaneous injections.[3] It is made using yeast cells rather than the standard Chinese hamster ovary cells.[3]
Clinical trials
Rheumatoid arthritis
The Phase IIa trial for rheumatoid arthritis[4] has completed with promising results leading to a licensing deal allowing phase III trials.[5] The results are to be presented in June 2010 at the European League Against Rheumatism (EULAR) meeting in Rome.[6] [7] Results showed that ALD518 in addition to MTX performs markedly better than MTX + placebo with a maximum ACR score, (ACR70, i.e. >70% of joints improved), after 16 weeks .[8]
2011: A phase 2 trial reported good results in patients not responsive to methotrexate (MTX).[9]
Oct 2013 : A phase 2B clinical trial has met its primary endpoint (ACR20 response at 12 weeks).[1] Adalimumab with MTX was included as a comparison in the trial.[1]
2014 : A dose ranging phase 2B trial was running.[10]
Crohn's disease
A phase II trial for Crohn's disease initially due to run until 2015.[11] has been prematurely discontinued after having recruited 71 patients out of 288.[12]
History
Clazakizumab was developed by Alder Biopharmaceuticals and licensed to Vitaeris, Inc. for worldwide marketing.[13]
See also
- Tocilizumab (Actemra) an anti-IL-6 receptor mAb
- Anti-IL-6, other anti-interleukin-6 agents
References
- ^ a b c Promising Phase IIb Data On Clazakizumab In Patients With Moderate-To-Severe Rheumatoid Arthritis To Be Presented At The 2013 Annual Meeting Of The American College Of Rheumatology
- ^ Cite error: The named reference
June2010was invoked but never defined (see the help page). - ^ a b http://www.xconomy.com/seattle/2008/09/18/alder-sets-stage-for-showdown-with-roche-with-fast-follower-antibody-drug-strategy/
- ^ http://clinicaltrials.gov/ct2/show/NCT00867516 Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis (ALD518-003)
- ^ "Bristol-Myers Squibb and Alder Biopharmaceuticals Enter Global Agreement on Rheumatoid Arthritis Biologic". 10 Nov 2009.
- ^ http://www.xconomy.com/seattle/2010/03/19/innovation-northwest-wrapup-alder-tekmira-acucela-other-emerging-little-biotechs/ March 2010
- ^ "New Data for Investigational Antibody Blocking IL-6 in Rheumatoid Arthritis Patients to be Presented at Annual Congress of European League Against Rheumatism". June 2010.
- ^ "EULAR 2010 Do not miss" (PDF). 2010.
- ^ "A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate". 2012. doi:10.1136/annrheumdis-2011-200704.
{{cite journal}}: Cite journal requires|journal=(help) - ^ Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
- ^ "Alder Gets $3.5M Milestone as Bristol-Myers Starts Crohn's Study". 27 Aug 2012.
- ^ http://www.clinicaltrials.gov/ct2/show/study/NCT01545050?show_locs=Y
- ^ https://globenewswire.com/news-release/2016/07/26/859067/0/en/Alder-BioPharmaceuticals-Reports-Second-Quarter-2016-Financial-and-Operating-Results.html
Further reading