SAN DIEGO - InflaRx N.V. (NASDAQ:IFRX), a clinical-stage biopharmaceutical company, presented new data at the American Thoracic Society 2024 International Conference today, suggesting that their drug vilobelimab may significantly reduce mortality in critically ill COVID-19 patients when used in combination with standard care medications.
The data comes from a post-hoc subgroup analysis of the PANAMO Phase III study, which focused on invasively mechanically ventilated COVID-19 patients in intensive care. The study involved 369 patients and supported the emergency use authorization granted by the U.S. Food and Drug Administration (FDA) in April 2023 for GOHIBIC (vilobelimab) for treating critically ill COVID-19 patients.
The analysis included 71 patients and showed a 28-day all-cause mortality rate of 6.3% in patients treated with vilobelimab in combination with either tocilizumab or baricitinib, compared to 40.9% in the placebo group. This represents an 84.6% relative reduction in mortality. At 60 days, the mortality was 16.4% for the treatment group versus 49.3% for the placebo group.
Vilobelimab, a monoclonal anti-human complement factor C5a antibody, is designed to block the biological activity of C5a, a key driver of inflammation, without hindering the innate immune system's defense mechanisms. While the drug has been granted an EUA for treating COVID-19, it remains investigational and has not received full FDA approval.
Dr. Camilla Chong, Chief Medical Officer of InflaRx, expressed enthusiasm about the potential of vilobelimab to save lives in the acute care setting. The company is committed to further research on the drug's utility in critically ill hospitalized patients.
The safety profile of vilobelimab was also assessed during the study, with no new safety concerns associated with its use in combination with tocilizumab or baricitinib. The demographics of the subgroups were comparable to the overall study population.
This report is based on a press release statement from InflaRx N.V. and its presentation at the ATS conference. It is important to note that vilobelimab is still under investigation and healthcare providers are advised to follow the guidance provided in the Fact Sheet for Healthcare Providers and FDA Letter of Authorization for more information on its use and safety.
InvestingPro Insights
Amid the promising clinical outcomes for InflaRx's vilobelimab, the company's financial health and market performance offer additional context for investors. According to real-time data from InvestingPro, InflaRx N.V. (NASDAQ:IFRX) holds a market capitalization of $88.32 million, reflecting the current investor valuation of the company. Notably, the firm has experienced a significant return over the last month, with a 14.07% increase in its stock price, suggesting growing investor confidence following recent developments.
InvestingPro Tips highlight that InflaRx has more cash than debt on its balance sheet, which is a positive sign of financial stability and may provide the company with the flexibility to continue its research and development efforts without the immediate pressure of financial constraints. Additionally, analysts have revised their earnings upwards for the upcoming period, indicating expectations of improved financial performance.
While these factors are encouraging, it's also crucial to consider that analysts do not anticipate the company will be profitable this year, and InflaRx has been quickly burning through cash. These points underscore the importance of closely monitoring the company's financials and the market's reception of its clinical advancements.
Interested readers can find more InvestingPro Tips for InflaRx, including detailed financial analysis and additional metrics, by visiting https://www.investing.com/pro/IFRX. For those seeking in-depth insights, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. In total, there are 12 additional InvestingPro Tips available that could further guide investment decisions regarding InflaRx N.V.
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