Pharmaceutical company inflaRx has received emergency use authorization from the FDA for its new antibody drug, vilobelimab, to treat critically ill Covid-19 patients. Vilobelimab is unique in that it does not target the virus or its spike protein, but rather a specific product of the complement system that triggers severe symptoms, such as inflammation and fatigue, when battling a pathogen. The targeted complement molecule for vilobelimab is C5a, which acts as a chemoattractant for other immune system mechanisms.
The drug was tested in phase one and two safety and efficacy trials in human volunteers, demonstrating a strong response in controlling severe symptoms. The phase three trial included 368 patients in nine countries worldwide, all suffering from severe Covid-19 and requiring ventilation. The treatment group had a 9% lower mortality rate than the placebo group, showing the drug to be a suitable therapy for patients with severe Covid-19.
While vilobelimab is not a miracle cure for Covid-19, it is a notable advancement in monoclonal antibody treatments. Combining vilobelimab with other effective monoclonal antibody treatments may improve disease outcomes even further. Additional research into possible combination options, such as monoclonal antibodies that target highly conserved regions of the spike or anti-ACE2 antibodies, should be explored.
In summary, vilobelimab received emergency use authorization from the FDA to treat critically ill Covid-19 patients. The drug targets a specific product of the complement system that triggers severe symptoms when battling a pathogen. The drug was tested in phase three trials and has shown to be a suitable therapy for patients with severe Covid-19. While the drug is not a miracle cure, it is a notable advancement in monoclonal antibody treatments, and further research into possible combination options should be explored.