InflaRx’s GOHIBIC Receives EMA Panel Approval for COVID-19 ARDS By Investing.com
JENA, Germany – InflaRx NV (NASDAQ: ), a biopharmaceutical company focused on improving the treatment of inflammatory diseases, has received a favorable 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 in adults with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) using ventilators and systemic corticosteroids.
The CHMP’s positive opinion is an important step towards full marketing authorization in the European Union, which is expected within 67 days. This follows an Emergency Authorization previously granted by the US Food and Drug Administration (FDA). The company expects the European Commission to approve the CHMP’s recommendations and issue a marketing authorization.
The PANAMO study, a multicenter Phase 3 trial, supports the CHMP’s position. This study, which was double-blind, placebo-controlled, and involved patients with COVID-19 in intensive care units, showed that vilobelimab improved survival rates. 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 exploring potential partnerships for distribution within the EU. The company expects that this commercial strategy will not significantly affect its cash burn rate.
GOHIBIC is approved for emergency use by the FDA in hospitalized adults with COVID-19, to be administered within 48 hours of initiation of mechanical ventilation or extracorporeal membrane oxygenation (ECMO). This authorization is temporary and subject to the duration of the declaration of a COVID-19 emergency.
Vilobelimab is a monoclonal antibody that targets the C5a component of the complement system, which plays a role in inflammation. Although the drug has shown promise in clinical trials, its safety and effectiveness continue to be tested, 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 of GOHIBIC’s anticipated approval. The drug is also being tested in the clinical platform by the Biomedical Advanced Research and Development Authority (BARDA) as a potential treatment for ARDS.
The information in this article is based on a press release from InflaRx NV
In other recent news, InflaRx NV reported significant progress 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 tested the efficacy of Gohibic, an intravenous anti-C5a monoclonal antibody developed by InflaRx. Despite the initial results showing that Gohibic did not meet its primary endpoint, the new analysis highlighted a significant reduction compared to the placebo in drainage canals, the number of total ulcers, and the International Hidradenitis Suppurative Score 4.
InflaRx also reported promising results from a Phase 2b study of vilobelimab, an anti-C5a antibody, in the treatment of hidradenitis suppurativa. The company presented positive data from a post-hoc group analysis of the PANAMO Phase III study, suggesting that vilobelimab may reduce mortality in critically ill patients with COVID-19.
The company’s investigational drug, vilobelimab, has been selected by the Biomedical Advanced Research and Development Authority for a Phase 2 clinical trial aimed at testing new treatments for acute respiratory distress syndrome. InflaRx also presented preclinical data on its novel C5aR inhibitor, INF904, at the European Meeting on Complementary and Human Infectious Diseases, demonstrating its potential as a potent anti-inflammatory agent. These latest updates underscore the continued progress in InflaRx’s research and development efforts.
InvestingPro Insights
The positive CHMP opinion for InflaRx’s GOHIBIC (vilobelimab) marks an important milestone for the company, which may impact its financial outlook. According to InvestingPro data, InflaRx’s market capitalization stands at $119.53 million, reflecting the company’s strong market valuation.
Despite the promising development, InvestingPro Tips highlights that InflaRx is a “cash-burner” and has been “unprofitable over the past twelve months.” This context is important as the company aims to commercialize GOHIBIC in Europe. The company’s statement that the commercial strategy will not significantly affect its cash burn rate is important given these financial considerations.
Interestingly, InflaRx has seen a “significant return over the past week,” with a 30.13% price gain over the past week. This recent stock performance may reflect investor optimism surrounding CHMP’s positive outlook. However, InvestingPro Tip warns that “the RSI suggests the stock is in overbought territory,” indicating that investors should carefully consider the current valuation.
For those looking for a more comprehensive analysis, InvestingPro offers 14 additional tips for InflaRx, providing a deeper understanding of the company’s financial health and market conditions as it navigates this important phase of drug development and potential commercialization.
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