New Antibody Treatment Discovered by Ward Lab Approved by FDA
By Lynn McCain | April 6 2023
After several decades of hard work by many scientists at the University of Michigan Medical School and elsewhere, an antibody (anti-C5a) has just been approved by the US FDA for treatment of humans who are septic and have developed lung infections with COVID-19, resulting in severe pulmonary dysfunction requiring external lung support. The antibody, anti-C5a, was originally developed in the Dr. Peter Ward laboratory in the early 2000s. The mAb was shown to dramatically reduce lung infections in polymicrobial sepsis in mice.
In the 1990s and early 2000s, Ward and postdoctoral fellows Drs. Renfeng Guo and Niels Riedemann developed a monoclonal antibody to human and mouse C5a. Guo and Riedemann, currently at InflaRx in Jena, Germany, continued this work, which led to a slightly modified antibody that was recently approved for use in COVID-19 patients. Referred to as vilobelimab, this antibody was shown to be effective for treatment of COVID-19 in humans and received approval in Europe for use in patients with sepsis. Soon thereafter, another article was published by the same group in Lancet Respiratory Medicine, one of the most highly respected medical journals in the world. Then on April 4, 2023, the FDA sent notification that this anti-C5a antibody was approved for use in the United States.
Ward commented on this achievement, “I am very proud of my colleagues and the many postdocs over the past 40 years for these accomplishments in this important medical area. I also greatly appreciate the support of individuals at the U-M Medical School. I think in the long run, this antibody will be used in septic patients and those patients with infectious complications who develop sepsis, and it will have substantial positive effects in the settings of infectious sepsis.”
Citations:
- Vlaar APJ, Lim EHT, de Bruin S, Rückinger S, Pilz K, Brouwer MC, Guo RF, Heunks LMA, Busch MH, van Paassen P, Riedemann NC, van de Beek D. The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19. Clin Transl Sci. 2022 Apr;15(4):854-858. doi: 10.1111/cts.13213. Epub 2022 Jan 14. PMID: 35029045; PMCID: PMC9010279.
- Vlaar APJ, Witzenrath M, van Paassen P, Heunks LMA, Mourvillier B, de Bruin S, Lim EHT, Brouwer MC, Tuinman PR, Saraiva JFK, Marx G, Lobo SM, Boldo R, Simon-Campos JA, Cornet AD, Grebenyuk A, Engelbrecht JM, Mukansi M, Jorens PG, Zerbib R, Rückinger S, Pilz K, Guo R, van de Beek D, Riedemann NC; PANAMO study group. Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Dec;10(12):1137-1146. doi: 10.1016/S2213-2600(22)00297-1. Epub 2022 Sep 7. PMID: 36087611; PMCID: PMC9451499.
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