JENA, Germany - InflaRx N.V. (NASDAQ:IFRX), a biopharmaceutical company focused on developing treatments for inflammatory diseases, has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its drug GOHIBIC (vilobelimab). The recommendation is for marketing authorization under exceptional circumstances for adults with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are on mechanical ventilation and systemic corticosteroids.
The CHMP's favorable opinion is a significant step towards full marketing authorization in the European Union, which is expected within 67 days. This follows the Emergency Use Authorization previously granted by the U.S. Food and Drug Administration (FDA). The company anticipates the European Commission to endorse the CHMP's recommendation and issue marketing authorization.
The PANAMO study, a multicenter Phase 3 trial, underpins the CHMP's position. This trial, which was double-blind, placebo-controlled, and involved patients with COVID-19 in intensive care units, demonstrated that vilobelimab improved survival rates. The findings revealed a 23.9% relative reduction in 28-day all-cause mortality compared to placebo.
InflaRx plans to commercialize GOHIBIC in Europe and is evaluating potential partnerships for distribution within the EU. The company expects that this commercial strategy will not significantly affect its cash burn rate.
GOHIBIC has been authorized for emergency use by the FDA for hospitalized adults with COVID-19, to be administered within 48 hours of starting invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). This authorization is temporary and contingent on the duration of the COVID-19 emergency declaration.
Vilobelimab is a monoclonal antibody targeting the C5a component of the complement system, which plays a role in inflammation. While the drug has shown promise in clinical trials, its safety and efficacy continue to be evaluated, and it has not yet received full FDA approval for any indication.
InflaRx will provide 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.
The information in this article is based on a press release statement from InflaRx N.V.
In other recent news, InflaRx N.V. has reported significant developments in its clinical trials and research. The company recently presented a post hoc analysis of the Phase 2b SHINE trial at the European Academy of Dermatology and Venereology Congress. The trial examined the efficacy of Gohibic, an intravenously administered anti-C5a monoclonal antibody developed by InflaRx. Despite initial results indicating 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.
InflaRx also reported promising results from a Phase 2b study of vilobelimab, an anti-C5a antibody, in treating hidradenitis suppurativa. The company revealed positive data from a post-hoc subgroup analysis of the PANAMO Phase III study, suggesting vilobelimab may decrease mortality rates in critically ill COVID-19 patients.
The company's investigational drug, vilobelimab, was selected by the Biomedical Advanced Research and Development Authority for a Phase 2 clinical study aimed at exploring new treatments for acute respiratory distress syndrome. InflaRx has also presented preclinical data on its novel oral C5aR inhibitor, INF904, at the European Meeting on Complement in Human Diseases, demonstrating its potential as a potent anti-inflammatory agent. These recent updates underscore the ongoing progress in InflaRx's research and development efforts.
InvestingPro Insights
The positive CHMP opinion for InflaRx's GOHIBIC (vilobelimab) marks a significant milestone for the company, potentially impacting its financial outlook. According to InvestingPro data, InflaRx's market capitalization stands at $119.53 million, reflecting the market's current valuation of the company's potential.
Despite the promising developments, InvestingPro Tips highlight that InflaRx is "quickly burning through cash" and is "not profitable over the last twelve months." This context is crucial as the company moves towards commercialization of GOHIBIC in Europe. The company's statement that the commercialization strategy will not significantly affect its cash burn rate is particularly relevant in light of these financial considerations.
Interestingly, InflaRx has seen a "significant return over the last week," with a 30.13% price total return in the past week. This recent stock performance may reflect investor optimism surrounding the CHMP's positive opinion. However, an InvestingPro Tip cautions that the "RSI suggests the stock is in overbought territory," indicating that investors should carefully consider the current valuation.
For those seeking a more comprehensive analysis, InvestingPro offers 14 additional tips for InflaRx, providing a deeper understanding of the company's financial health and market position as it navigates this crucial phase of drug development and potential commercialization.
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