InflaRx Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum - Seite 2

The Company has received Fast Track and Orphan Drug (OD) designations by the U.S. Food and Drug Administration (FDA), as well as OD designation by the European Medicines Agency (EMA) for the treatment of PG.

About Pyoderma Gangrenosum

Ulcerative PG is a rare, non-infectious, neutrophilic dermatosis recurrent skin disorder characterized by painful, necrolytic, cutaneous ulcers that can rapidly progress. PG is considered an autoimmune disease of the skin, but the underlying cause of PG is not known in detail. PG lesions are histologically characterized by pronounced infiltration of neutrophils, and activated neutrophils surrounding the ulcers are believed to be disease drivers. PG typically occurs in patients between the ages of 40 and 60, and PG patients often also suffer from other autoimmune disorders, such as inflammatory bowel disease and rheumatoid arthritis. There are currently no approved drugs for the treatment of PG in the U.S. or in Europe, and there is no established standard of care based on controlled studies.

About Vilobelimab

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) in the U.S. 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). A Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome receiving IMV or ECMO is currently under review by the European Committee for Medicinal Products for Human Use. In addition to development in COVID-19, vilobelimab is being developed for other debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum.