InflaRx N.V. has announced that its drug, GOHIBIC (vilobelimab), has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The recommendation supports marketing authorization, under exceptional circumstances, for adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who require mechanical ventilation and are receiving systemic corticosteroids. This decision marks a significant advancement in the treatment of severe COVID-19 complications.
The CHMP's favorable opinion is a crucial step toward securing full marketing authorization within the European Union, anticipated within 67 days. This follows the Emergency Use Authorization granted by the U.S. Food and Drug Administration (FDA). The European Commission is expected to endorse the CHMP's recommendation and grant marketing authorization.
PANAMO Trial Results
The CHMP's decision was primarily based on the results of the PANAMO study, a multicenter Phase 3 trial. This double-blind, placebo-controlled study involved COVID-19 patients in intensive care units and demonstrated that vilobelimab significantly improved survival rates. The trial revealed a 23.9% relative reduction in 28-day all-cause mortality compared to the placebo group. These findings underscore the potential of vilobelimab to address critical unmet needs in managing severe COVID-19.
Commercialization Strategy
InflaRx is actively planning the commercialization of GOHIBIC in Europe and is exploring potential partnerships for distribution within the EU. The company anticipates that this commercial strategy will not significantly impact its cash burn rate, ensuring sustainable market entry and growth.
GOHIBIC has already received Emergency Use Authorization from the FDA for hospitalized adults with COVID-19, specifically for administration within 48 hours of initiating invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). This authorization is temporary and contingent on the duration of the COVID-19 emergency declaration.
Mechanism of Action and Further Evaluation
Vilobelimab is a monoclonal antibody that targets the C5a component of the complement system, a key player in inflammation. While clinical trials have shown promising results, the safety and efficacy of the drug are still under evaluation, and it has not yet received full FDA approval for any indication. InflaRx is committed to providing annual updates to the EMA as part of the terms for GOHIBIC's anticipated approval. The drug is also included in a clinical platform study by the Biomedical Advanced Research and Development Authority (BARDA) as a potential therapy for treating ARDS.
Additional Clinical Data
InflaRx has also presented a post hoc analysis of the Phase 2b SHINE trial at the European Academy of Dermatology and Venereology Congress. Although initial results indicated that Gohibic did not meet its primary endpoint, the new analysis highlighted substantial placebo-adjusted reductions in draining tunnels, total lesion counts, and the International Hidradenitis Suppurative Score 4. Furthermore, positive data from a post-hoc subgroup analysis of the PANAMO Phase III study suggested that vilobelimab may decrease mortality rates in critically ill COVID-19 patients.
Financial Context
Despite these promising developments, InvestingPro Tips indicate that InflaRx is "quickly burning through cash" and is "not profitable over the last twelve months." However, the company's stock has seen a "significant return over the last week," reflecting investor optimism surrounding the CHMP's positive opinion. Investors should carefully consider the current valuation, as the "RSI suggests the stock is in overbought territory."
