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) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). This authorization is under exceptional circumstances and applies to patients receiving systemic corticosteroids as part of standard care and invasive mechanical ventilation.
The CHMP's positive 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 trial demonstrated that vilobelimab improved survival, with a 23.9% relative reduction in 28-day all-cause mortality compared to placebo in the global data set, a statistically significant outcome published in The Lancet Respiratory Medicine.
Clinical Efficacy and Safety Profile
The PANAMO trial enrolled patients who were critically ill with COVID-19-induced ARDS, a condition characterized by severe inflammation and lung injury. Vilobelimab, a first-in-class monoclonal anti-human complement factor C5a antibody, works by blocking the biological activity of C5a, a key driver of the inflammatory response. This mechanism is designed to control tissue and organ damage associated with excessive inflammation while preserving the crucial defense mechanism of the innate immune system.
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, stated, "The positive CHMP opinion reflects a significant milestone in the development of our anti-C5a antibody vilobelimab, and, together with the previously received Emergency Use Authorization granted by the FDA, further validates its therapeutic potential." He also noted the ongoing need for more effective treatments for SARS-CoV-2-induced ARDS patients in the ICU.
While the CHMP recommends marketing authorization under exceptional circumstances due to the rarity of the disease making comprehensive data collection challenging, InflaRx will provide annual updates to the EMA on a clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as a potential therapy for ARDS.
Commercialization Strategy
InflaRx intends to commercialize GOHIBIC® in Europe under its proprietary brand name. The company is also considering commercial distribution options with potential partners in the EU, an approach that is not expected to significantly impact its cash burn rate.
Adverse Reactions and Monitoring
Limited clinical data are available for GOHIBIC. Healthcare providers are advised to monitor patients for signs and symptoms of new infections during and after treatment with GOHIBIC, as the drug has been associated with an increased risk of serious infections. Hypersensitivity reactions have also been observed. Common adverse reactions (incidence ≥3%) include pneumonia, sepsis, delirium, pulmonary embolism, hypertension, and deep vein thrombosis.
Vilobelimab: A Novel Approach to ARDS Treatment
Vilobelimab represents a novel approach to treating ARDS by selectively targeting C5a, a potent inflammatory mediator involved in various inflammatory diseases. In addition to its development for COVID-19, vilobelimab is also being developed for other inflammatory indications, including pyoderma gangrenosum (PG), for which it has received orphan drug designation from both the FDA and EMA, as well as fast track designation from the FDA.
