Mavrilimumab
Monoclonal antibody
N
Y (what is this?) (verify) 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
- ^ a b "Statement On A Nonproprietary Name Adopted By The USAN Council: Mavrilimumab" (PDF). American Medical Association. Archived from the original (PDF) on 2012-09-28.
- ^ a b Burmester GR, Feist E, Sleeman MA, Wang B, White B, Magrini F (September 2011). "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. doi:10.1136/ard.2010.146225. PMC 3147227. PMID 21613310.
- ^ a b Burmester GR, Weinblatt ME, McInnes IB, Porter D, Barbarash O, Vatutin M, et al. (EARTH Study Group) (September 2013). "Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis". Annals of the Rheumatic Diseases. 72 (9): 1445–52. doi:10.1136/annrheumdis-2012-202450. PMC 3756523. PMID 23234647.
- ^ Di Franco M, Gerardi MC, Lucchino B, Conti F (12 March 2014). "Mavrilimumab: an evidence based review of its potential in the treatment of rheumatoid arthritis". Core Evidence. 9: 41–8. doi:10.2147/CE.S39770. PMC 3958547. PMID 24648832.
- ^ Walsh N (February 21, 2017). "Agent that Targets GM-CSF Shows Promise in RA". MedPage Today.
Novel monoclonal antibody was rapidly effective in mild-to-moderate disease
- ^ "SEC Filing | Kiniksa Pharmaceuticals".
- ^ De Luca G, Cavalli G, Campochiaro C, Della-Torre E, Angelillo P, Tomelleri A, et al. (16 June 2020). "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. doi:10.1016/S2665-9913(20)30170-3. PMC 7430344. PMID 32835256.
- ^ "Kiniksa Outlines Next Steps for the Development of Mavrilimumab | Kiniksa Pharmaceuticals".
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Monoclonal antibodies for the immune system
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- #WHO-EM
- ‡Withdrawn from market
- Clinical trials:
- †Phase III
- §Never to phase III
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