InflaRx N.V. (Nasdaq: IFRX) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for GOHIBIC (vilobelimab). This authorization, under exceptional circumstances, targets the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard care and invasive mechanical ventilation (IMV), with or without extracorporeal membrane oxygenation (ECMO).
The positive CHMP opinion is based on data from the Phase 3 PANAMO trial, a multicenter, 1:1 randomized, double-blind, placebo-controlled study involving invasively mechanically ventilated COVID-19 patients in intensive care units. The results, published in The Lancet Respiratory Medicine, demonstrated that vilobelimab treatment improved survival, with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.
Clinical Efficacy and Safety
The PANAMO trial enrolled patients receiving standard of care, including systemic corticosteroids. Vilobelimab was administered intravenously in addition to this standard of care. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included measures of organ function and duration of mechanical ventilation.
While the full prescribing information details specific adverse reactions, the most common (incidence ≥3%) included pneumonia, sepsis, delirium, pulmonary embolism, hypertension, and deep vein thrombosis. Healthcare providers are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events.
Vilobelimab: A Novel Anti-C5a Antibody
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody. It selectively blocks the biological activity of C5a, a potent inflammatory mediator, while leaving the formation of the membrane attack complex (C5b-9) intact, preserving an important defense mechanism of the innate immune system. Pre-clinical studies have shown that vilobelimab controls inflammatory response-driven tissue and organ damage by specifically blocking C5a.
Commercialization and Future Plans
InflaRx plans to commercialize GOHIBIC in Europe under its proprietary brand name. The company is considering commercial distribution options with potential partners in the EU. Under the terms of the anticipated EU approval, InflaRx will provide annual updates to the EMA on the clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA), in which vilobelimab is included as one of three potential therapies for treating ARDS.
Prior FDA Emergency Use Authorization
GOHIBIC (vilobelimab) has already been granted an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO. This authorization remains valid for the duration of the COVID-19 public health emergency.
