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Coronaviruses

Breakthrough in COVID-19 Treatment: Vilobelimab Shows Promising Results

Strategic Insights

— 2 min read

Researchers have made significant progress in the development of a new treatment for COVID-19, with the monoclonal antibody vilobelimab demonstrating life-saving potential in the management of severe cases of the disease. According to a recent study, vilobelimab selectively inhibits C5a-induced inflammation, a key factor in the development of acute respiratory distress syndrome (ARDS) and sepsis.

The study, published in the International Journal of Molecular Sciences, found that patients treated with vilobelimab had a significantly lower risk of death by day 28 and 60 compared to those receiving a placebo. The United States Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for vilobelimab, and the European Commission has granted marketing authorization for the treatment of adult patients with severe ARDS.

Key Takeaways:

  • Vilobelimab targets human complement component 5a (C5a) in plasma, providing therapeutic promise in the management of COVID-19-induced ARDS.
  • The randomized, multicenter placebo-controlled Phase III study of vilobelimab found that patients treated with vilobelimab had a significantly lower risk of death by day 28 and 60.
  • The FDA issued an EUA for Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
  • The European Commission granted marketing authorization for Gohibic (vilobelimab) for the treatment of adult patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-induced ARDS who are receiving systemic corticosteroids as part of standard of care and receiving IMV with or without ECMO.
  • The Commission's approval is based on the clinical data demonstrating its life-saving potential in the management of COVID-19-induced ARDS.
  • The research was conducted by InflaRx GmbH, with financial support from Inflarx.

Statistics:

  • The study involved 252 patients, with 126 receiving vilobelimab and 126 receiving a placebo.
  • The risk of death by day 28 and 60 was significantly lower in patients treated with vilobelimab compared to those receiving a placebo.
  • Vilobelimab was shown to be life-saving in the management of COVID-19-induced ARDS, with a clinical data demonstrating its potential in reducing mortality rates.

Sources:

  • NewsRx. Recent Findings in COVID-19 Described by Researchers from InflaRx GmbH (A Targeted Blockade of Terminal C5a Is Critical to Management of Sepsis and Acute Respiratory Distress Syndrome: The Mechanism of Action of Vilobelimab). Medical Letter on the CDC & FDA. November 2, 2025; p 146.
  • International Journal of Molecular Sciences. A Targeted Blockade of Terminal C5a Is Critical to Management of Sepsis and Acute Respiratory Distress Syndrome: The Mechanism of Action of Vilobelimab. 2025;26(19):9628.

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