Welcome to our dedicated page for InflaRx N.V. news (Ticker: IFRX), a resource for investors and traders seeking the latest updates and insights on InflaRx N.V. stock.
InflaRx N.V. (NASDAQ: IFRX) is a clinical-stage biopharmaceutical company dedicated to discovering and developing inhibitors using C5a technology, primarily in Germany and the United States. The company focuses on targeting the complement activation factor known as C5a, an inflammatory mediator linked to various autoimmune and inflammatory diseases.
InflaRx's lead product candidate is vilobelimab (formerly known as IFX-1), a first-in-class, intravenously delivered anti-C5a monoclonal antibody. Vilobelimab has completed Phase IIb clinical trials for treating hidradenitis suppurativa, a rare and chronic inflammatory skin disease, as well as for ANCA-associated vasculitis, a life-threatening autoimmune condition, and pyoderma gangrenosum, a chronic inflammatory skin disorder. Additionally, the company is exploring vilobelimab’s potential in treating oncological diseases.
InflaRx is also developing IFX-2, another anti-inflammatory and autoimmune disease treatment currently in pre-clinical development. The company’s proprietary C5a/C5aR technology enables the creation of potent and specific inhibitors, positioning InflaRx as a pioneer in this niche therapeutic area.
The company has established a co-development agreement with Beijing Defe, enhancing its research and development capacity. InflaRx's innovative therapies aim to significantly improve patient outcomes in diseases with substantial unmet medical needs.
InflaRx announced that its drug GOHIBIC (vilobelimab) has been selected by BARDA for a Phase 2 clinical trial aimed at treating acute respiratory distress syndrome (ARDS). The trial will be conducted at around 60 U.S. sites, enrolling 600 adults with ARDS from various causes. Vilobelimab will be one of three drugs tested, with each drug's safety and efficacy evaluated separately against a placebo. Key endpoints include all-cause mortality at Day 28, hospitalization duration, ICU days, and other efficacy measures. The results will inform Phase 3 trial designs and identify patient subpopulations likely to benefit from these treatments.
InflaRx hosted a virtual R&D event showcasing their oral small molecule C5aR inhibitor, INF904. The event detailed its potential in treating Chronic Spontaneous Urticaria (CSU) and Hidradenitis Suppurativa (HS), both representing multi-billion-dollar markets. INF904's Phase 2a clinical trial for CSU and HS will start by late 2024, with results expected by summer 2025. The trial aims to evaluate safety, pharmacokinetics, and clinical benefits. InflaRx expects their strong financial position to fund operations into 2026, supporting further clinical advancements. The company sees INF904 as a pipeline-in-a-product, potentially addressing broader therapeutic areas.
InflaRx N.V. (Nasdaq: IFRX) presented new data at the ATS 2024 International Conference showing significant improvements in mortality rates for critically ill COVID-19 patients treated with vilobelimab in combination with tocilizumab or baricitinib. The analysis, derived from the PANAMO Phase III trial, demonstrates an 84.6% relative reduction in 28-day all-cause mortality and a 66.7% relative reduction in 60-day all-cause mortality compared to placebo. Safety assessments revealed no major concerns related to the combination therapy. This data further supports the FDA's emergency use authorization for vilobelimab in critically ill COVID-19 patients.
InflaRx N.V. reported financial results for Q1 2024 and provided updates on INF904 and Phase III vilobelimab trials. They highlighted plans to initiate Phase IIa in CSU and HS by 2024 end, with data availability in 2025. The vilobelimab trial for PG is ongoing, with an interim analysis in 2025. Cash reserves of €85.8 million expected to fund operations into 2026.
InflaRx N.V. (Nasdaq: IFRX) will report its first quarter 2024 financial and operating results on May 8, 2024. They will host a virtual R&D event on June 5, 2024, focusing on the development of their new oral small molecule C5aR inhibitor, INF904, and its potential in treating chronic spontaneous urticaria and hidradenitis suppurativa. Key opinion leaders will provide insights into the commercial opportunity and therapeutic potential of INF904.
FAQ
What is InflaRx N.V.'s primary focus?
What is vilobelimab?
Which diseases is vilobelimab being developed to treat?
What is the status of IFX-2?
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What is C5a?
Does InflaRx have any partnerships?
What technology does InflaRx use for its products?
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