InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA) - Seite 2
Gohibic (vilobelimab) has received an EUA in the U.S. for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO. The Company is continuing discussions with the Food and Drug Administration (FDA) related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic (vilobelimab) in the United States. For additional information related to the EUA, please visit www.Gohibic.com
Upcoming scientific and investor events
InflaRx’s management will participate in the following conferences in the coming weeks:
World Antimicrobial Resistance Congress
September 7-8, 2023, Philadelphia, PA, USA
- Panel discussion, September 7, 11:20 am EDT with Prof. Niels C. Riedemann, CEO
H.C. Wainwright 25th Annual Global Investment Conference
September 11-13, 2023, New York, NY, USA
- Company presentation on September 11th, 11:00 am EDT (webcast)
7th Annual Complement-Based Drug Development Summit
September 11-13, 2023, Boston, MA, USA
- Presentation “The Life-Saving Anti-Inflammatory Potential of Blocking the C5a / C5aR Signaling Pathway,” by Prof. Riedemann, September 12th, 5:10 pm EDT
- Panel “What are the Future Applications of Complement Therapeutics; What Will the Landscape Look Like in 5 Years’ Time?,” September 13th, 4:30 pm EDT
BioPharm America 2023
September 11-13, 2023, Research Triangle Park, USA
- Scheduled corporate and investor meetings
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Guggenheim Securities 5th Annual Inflammation & Immunology (I&I) Conference
November 6-7, 2023, New York, NY, USA
BIO-Europe
November 6-8, 2023, Munich, Germany
- Company presentation and scheduled corporate and investor meetings
About Viral Sepsis in SARS-CoV-2 Infection
Invasively mechanically ventilated patients who have tested positive for COVID-19 fulfill the criteria set by the current third international consensus definitions for sepsis, which define sepsis as a “life-threatening organ dysfunction caused by a dysregulated host response to infection.” Viral infection-mediated sepsis is believed to be driven by the inflammatory immune response of a patient to the virus. Observational studies have suggested that the inflammatory response, endothelial permeability and coagulopathy observed in severe COVID-19 are associated with strong complement activation and C5a generation as part of the human innate immune response. By targeting the complement component C5a in critically ill and invasively mechanically ventilated COVID-19 patients, vilobelimab is believed to block a key mediator of this inflammatory host response induced by severe SARS-CoV-2 infection and, thus, potentially offers a mechanism of action that may be independent of the viral variant that has caused such inflammatory response. Inhibition of the C5a / C5aR pathway has been demonstrated to be beneficial or lifesaving in various pre-clinical models of viral lung injury and viral sepsis, including models investigating influenza and corona viruses.