Jena, Germany, June 24, 2024 – InflaRx N.V., a biopharmaceutical company, has announced that GOHIBIC (vilobelimab) has been selected by the Biomedical Advanced Research and Development Authority (BARDA) for a Phase 2 clinical platform study. This study aims to explore potential new options for the treatment of acute respiratory distress syndrome (ARDS), a condition with no approved therapy currently available.
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, expressed the significance of this selection, highlighting the potential of vilobelimab as a potent anti-inflammatory agent in ARDS due to its inhibition of C5a and a host-directed mechanism of action.
The Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled study expected to begin later this year. It will be conducted at approximately 60 sites in the U.S., targeting a total enrollment of 600 hospitalized adults with ARDS. The trial will assess the safety and efficacy of vilobelimab, alongside two other investigational drugs, each in its own patient cohort compared against placebo.
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, designed to block the biological activity of C5a effectively. It has shown promise in controlling inflammatory response-driven tissue and organ damage in pre-clinical studies. The drug is also being developed for various inflammatory indications, including pyoderma gangrenosum.
The primary endpoint of the trial will be all-cause mortality at Day 28, with additional efficacy endpoints including days of hospitalization, ICU days, and daily oxygenation requirements. The study aims to identify subsets of ARDS patients who may benefit from specific host-directed therapeutics, informing the design of future Phase 3 studies.
ARDS is a severe lung condition caused by various factors, including severe pneumonia and sepsis, leading to high mortality rates among hospitalized patients. The condition is driven by the body's immune response to an underlying inflammatory insult, contributing to lung inflammation and tissue damage.
Vilobelimab has previously been granted an emergency use authorization (EUA) for the treatment of COVID-19 in hospitalized adults requiring invasive mechanical ventilation or ECMO, based on significant survival improvements observed in a multinational study.
