JENA, Germany - InflaRx N.V. (NASDAQ:IFRX), a biopharmaceutical company, announced today that its investigational drug, GOHIBIC (vilobelimab), has been chosen by the Biomedical Advanced Research and Development Authority (BARDA) for a Phase 2 clinical study. The study aims to explore new treatments for acute respiratory distress syndrome (ARDS), a critical care condition with no approved therapy.
The Phase 2 trial, which is set to start later this year, will be a multicenter, randomized, double-blind, placebo-controlled study. It will involve about 60 sites across the U.S. and target 600 hospitalized adults with ARDS, excluding those with trauma, large volume aspiration, or transfusion-related cases.
Vilobelimab will be one of three host-directed investigational drugs evaluated in the study. Each of the three drug cohorts will enroll 200 patients, with half receiving the investigational drug and the other half a placebo, in addition to standard care.
The primary endpoint of the trial will be all-cause mortality at Day 28, with additional efficacy endpoints including mortality at other time periods, hospital and ICU stay duration, oxygenation needs, and mechanical ventilation requirements, among other efficacy and biomarker measures.
Vilobelimab, a monoclonal anti-human complement factor C5a antibody, has demonstrated control over inflammatory response-driven tissue and organ damage by specifically blocking C5a in pre-clinical studies. It is also being developed for other inflammatory conditions, including pyoderma gangrenosum.
ARDS is a life-threatening lung condition caused by various factors, including severe infections like influenza and SARS-CoV-2. It is characterized by an inflammatory response leading to lung damage. Currently, no medications are approved to treat ARDS.
Vilobelimab has been granted an Emergency Use Authorization (EUA) for treating COVID-19 in hospitalized adults requiring invasive mechanical ventilation or ECMO when initiated within 48 hours. However, vilobelimab is still an investigational drug not approved by the FDA for any indication outside of the EUA for COVID-19.
This Phase 2 platform study will collect data to define patient subsets that may benefit from specific host-directed therapeutics, informing the design of Phase 3 studies and identifying a patient subpopulation most likely to benefit from each drug candidate.
The information in this article is based on a press release statement from InflaRx N.V.
In other recent news, clinical-stage biopharmaceutical company InflaRx N.V. revealed encouraging data from a post-hoc subgroup analysis of the PANAMO Phase III study at the American Thoracic Society 2024 International Conference.
The data suggests that vilobelimab, their investigational drug, used in combination with standard care medications, may significantly decrease mortality rates in critically ill COVID-19 patients. 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 involved 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.
These recent developments highlight the potential of vilobelimab in the treatment of severe COVID-19 cases, although it remains investigational and has not received full FDA approval. 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. InflaRx remains committed to further research on the drug's utility in critically ill hospitalized patients.
InvestingPro Insights
InflaRx N.V. (NASDAQ:IFRX), while advancing in the clinical development of its promising drug GOHIBIC, presents a mixed financial landscape according to recent InvestingPro data. With a market capitalization of 90.68 million USD, the company's financial status reflects a challenging environment, as evidenced by a negative gross profit margin of -659.42% for the last twelve months as of Q1 2024.
This indicates that the company is currently not generating a profit from its revenues, which aligns with the fact that analysts do not expect InflaRx to be profitable this year, as per InvestingPro Tips.
Despite these challenges, InflaRx holds a notable cash position compared to its debt, suggesting a degree of financial resilience. Moreover, the company's liquid assets surpass its short-term obligations, providing some financial flexibility in the near term.
With analysts anticipating sales growth in the current year and two analysts having revised their earnings upwards for the upcoming period, there is a sense of cautious optimism around the company's commercial prospects. Still, it is important to note that InflaRx is trading at a high revenue valuation multiple, which may raise concerns about the stock's current valuation relative to its financial performance.
Investors interested in a deeper dive into InflaRx's financial health and future prospects can find additional insights and tips on InvestingPro. There are currently 10 additional InvestingPro Tips available, which can be accessed at https://www.investing.com/pro/IFRX. Remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering a valuable resource for informed investment decisions.
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