InflaRx N.V. has announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). This approval marks a significant milestone as GOHIBIC becomes the first and only treatment approved in the European Union for this life-threatening condition.
The approval is specifically for patients who are receiving systemic corticosteroids as part of standard care and are undergoing invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO). The marketing authorization is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Clinical Evidence Supporting Approval
The EC's decision is supported by data from the multicenter Phase 3 PANAMO trial, a 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.
According to InflaRx, the all-cause mortality rate at 28 days was 32% in the Gohibic group and 42% in the placebo group. The trial enrolled 368 patients, with 177 receiving InflaRx’s therapy and 191 receiving placebo.
Mechanism of Action
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody. It works by selectively binding to free C5a, thereby blocking its biological activity and controlling the inflammatory response that drives tissue and organ damage in ARDS. This mechanism leaves the formation of the membrane attack complex (C5b-9) intact, preserving an important defense mechanism of the innate immune system.
Exceptional Circumstances Approval
The marketing authorization was granted under exceptional circumstances, a pathway reserved for situations where comprehensive data collection is challenging due to the rarity or complexity of the disease. As part of the approval, InflaRx will provide annual updates to the European Medicines Agency (EMA) based on data from a 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.
Safety Profile and Adverse Reactions
While GOHIBIC has demonstrated efficacy in reducing mortality, it is 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, pneumothorax, deep vein thrombosis, and various infections.
Future Plans
InflaRx is currently evaluating commercial partnering and distribution options in the EU and anticipates that this approach will not significantly impact its cash burn rate. The company is also developing INF904, an oral C5aR inhibitor, for immune-dermatology indications and testing vilobelimab for pyoderma gangrenosum, an autoinflammatory disease.
