New German Antibody Shows Promise for Severe COVID-19 Treatment

A novel antibody known as Vilobelimab has been developed to inhibit the human complement factor C5a, thereby dampening inflammatory responses associated with severe COVID-19 cases. This antibody is also being tested for use in treating the inflammatory skin condition Pyoderma gangraenosum.

Vilobelimab is a targeted inhibitor of the soluble human complement fragment C5a. By blocking C5a, the antibody aims to mitigate the inflammatory reaction triggered by severe SARS-CoV-2 infections. It has been approved for treating adult patients suffering from acute respiratory distress syndrome (ARDS) induced by SARS-CoV-2, particularly those who are receiving systemic corticosteroids and invasive mechanical ventilation, with or without extracorporeal membrane oxygenation.

The company behind this development, Inflarx GmbH, began its research in March 2020, shortly after the onset of the COVID-19 pandemic. Initially, the company funded the Phase II study for COVID-19 patients on its own. However, in May 2021, the German government launched a funding program of EUR300 million, which later provided approximately EUR33 million to Inflarx, significantly advancing the clinical development of Vilobelimab. The antibody received an emergency use authorization in the United States in April 2023 and was granted European Union approval in January 2025.

Research conducted by a team led by Professor Dr. Peter Ward at the University of Michigan has revealed important insights into the role of C5a in severe inflammatory and septic conditions. Despite initial findings from the U.S., the development of Vilobelimab was conducted within Germany, supported by new patents, establishing it as a homegrown product.

Preclinical studies have highlighted C5a as a significant enhancer of inflammatory responses during life-threatening infections, including sepsis caused by various viral and bacterial pathogens. The need for therapies that function independently of specific pathogens is crucial, especially as a part of pandemic preparedness strategies. It has been suggested that if such strategies had been available at the beginning of the pandemic, many critically ill patients could have been treated effectively. Data indicates that nearly all patients intubated during the peak of the pandemic met ARDS criteria.

While the current incidence of COVID-19 related ARDS is thankfully low, the potential for changing vaccination rates or virus mutations could lead to an increase in severe cases in the future. There is a clear objective to have medications readily available for new viral pandemics, allowing for timely development of targeted antiviral treatments and vaccines against emerging pathogens. Vilobelimab may play a significant role in this regard, with ongoing clinical trials investigating its efficacy.

In addition to its use in COVID-19, Vilobelimab is also being studied for its effectiveness in treating Pyoderma gangraenosum, a rare and painful inflammatory skin disorder characterized by ulcerative lesions. Currently, no approved treatments exist for this condition in either the United States or Europe.

In the context of COVID-19, Gohibic, the U.S. brand name for Vilobelimab, is available under emergency authorization, but it has yet to be released in Germany. The company is exploring various commercial partnerships and distribution channels within the European Union.