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
- Statement On A Nonproprietary Name Adopted By The USAN Council: Mavrilimumab American Medical Association^
- 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, September 2011^
- Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis Annals of the Rheumatic Diseases, September 2013^