Chemistry:Mavrilimumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | GM-CSF receptor alpha chain |
| Clinical data | |
| ATC code |
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| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| ChemSpider |
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| UNII | |
| Chemical and physical data | |
| Formula | C6706H10438N1762O2104S54 |
| Molar mass | 151140.74 g·mol−1 |
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Mavrilimumab is a human monoclonal antibody[1] that inhibits human granulocyte macrophage colony-stimulating factor receptor (GM-CSF-R).[2]
Mavrilimumab was discovered as CAM-3001 by Cambridge Antibody Technology and is being developed by MedImmune, Inc.[1] as an investigational drug for the treatment of rheumatoid arthritis
Mavrilimumab has been studied in a phase 1 dose-ranging trial[2] and a phase 2a clinical trial, both sponsored by Medimmune.[3] The phase 2a trial, which studied mavrilimumab doses of up to 100 mg, reported that 55.7% of subjects met the primary endpoint of a ≥1.2 decrease from baseline in disease activity scores at week 12 (vs. only 34.7% of placebo subjects).[3]
In 2013, two further clinical studies were reported to be underway in rheumatoid arthritis patients to investigate these effects further.[4]
In early 2017 the phase IIb study was reported to be showing promising results.[5]
In 2017, Kiniksa licensed Mavrilimumab from MedImmune.[6]
It was studied in 2020 to see if it could improve the prognosis for patients with COVID-19 pneumonia and systemic hyperinflammation. One small study indicated some beneficial effects of treatment with mavrilimumab compared with those who were not.[7]
In April 2021, Kiniksa outlined the next steps for development of Mavrilimumab - including in COVID-19–related acute respiratory distress syndrome (ARDS), giant cell arteritis (GCA), and rheumatoid arthritis (RA). “Recent favorable interactions with the FDA, based upon the clinical data generated with mavrilimumab in COVID-19-related ARDS, giant cell arteritis, and rheumatoid arthritis, underscore the broad utility of mavrilimumab and define a regulatory pathway for Phase 3 clinical development for each indication,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “We believe the ongoing Phase 3 study of mavrilimumab in COVID-19-related ARDS represents the fastest path to potential registration for the asset, and there remains a significant unmet need in these patients. Enrollment in our Phase 3 clinical trial is ongoing, and we expect data in the first quarter of 2022.”.[8]
References
- ↑ 1.0 1.1 "Statement On A Nonproprietary Name Adopted By The USAN Council: Mavrilimumab". American Medical Association. http://www.ama-assn.org/resources/doc/usan/mavrilimumab.pdf.
- ↑ 2.0 2.1 "Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-α, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study". Annals of the Rheumatic Diseases 70 (9): 1542–9. September 2011. doi:10.1136/ard.2010.146225. PMID 21613310.
- ↑ 3.0 3.1 "Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis". Annals of the Rheumatic Diseases 72 (9): 1445–52. September 2013. doi:10.1136/annrheumdis-2012-202450. PMID 23234647.
- ↑ "Mavrilimumab: an evidence based review of its potential in the treatment of rheumatoid arthritis". Core Evidence 9: 41–8. 12 March 2014. doi:10.2147/CE.S39770. PMID 24648832.
- ↑ Walsh, Nancy (February 21, 2017). "Agent that Targets GM-CSF Shows Promise in RA". MedPage Today. http://www.medpagetoday.com/mastery-of-medicine/rheumatology-mastery-in-ra/63286. "Novel monoclonal antibody was rapidly effective in mild-to-moderate disease"
- ↑ "SEC Filing | Kiniksa Pharmaceuticals". https://investors.kiniksa.com/node/7611/html.
- ↑ "GM-CSF blockade with mavrilimumab in severe COVID-19 pneumonia and systemic hyperinflammation: a single-centre, prospective cohort study". The Lancet Rheumatology 2 (8): e465–e473. 16 June 2020. doi:10.1016/S2665-9913(20)30170-3. PMID 32835256.
- ↑ "Kiniksa Outlines Next Steps for the Development of Mavrilimumab | Kiniksa Pharmaceuticals". https://investors.kiniksa.com/news-releases/news-release-details/kiniksa-outlines-next-steps-development-mavrilimumab.
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