InflaRx N.V. develops anti-inflammatory therapeutics that target the complement system through proprietary anti-C5a and anti-C5aR technologies. Its lead program, izicopan, is an orally administered small-molecule inhibitor of C5a-induced signaling via the C5a receptor, and vilobelimab is an intravenously delivered anti-C5a monoclonal antibody that selectively binds free C5a.
Company news commonly covers izicopan clinical-development strategy, preclinical pharmacology data, complement-mediated inflammatory disease programs, financial results, ordinary-share financings, Nasdaq listing compliance, annual meeting matters and investor communications. Updates also address the company’s operating group, which includes wholly owned subsidiaries in Germany and the United States.
InflaRx N.V. (Nasdaq: IFRX) has secured Fast Track and Orphan Drug designations from the FDA for vilobelimab to treat pyoderma gangrenosum (PG) and plans to submit an EUA for critically ill COVID-19 patients. The company reported €14.4 million in grant income during Q2 2022, maintaining €91.8 million in cash and equivalents to fund operations until late 2024. The net loss for the first half of 2022 was €13.5 million, a decrease from €20.9 million in 2021, while R&D expenses rose to €21.7 million due to ongoing clinical studies.
InflaRx (Nasdaq: IFRX) announced it will submit an Emergency Use Authorization (EUA) request for vilobelimab, an anti-C5a monoclonal antibody, after positive discussions with the FDA. The company plans to file the application by the end of Q3 2022, following encouraging results from the Phase III PANAMO study, which showed a 23.9% relative reduction in 28-day all-cause mortality in critically ill COVID-19 patients. With rising COVID-19 cases, the urgency for effective treatments remains high.
InflaRx N.V. (Nasdaq: IFRX) announced that the U.S. FDA granted Fast Track designation for its monoclonal antibody vilobelimab in treating ulcerative pyoderma gangrenosum (PG). This designation follows the orphan drug designation earlier granted by both the FDA and EMA. In a Phase IIa study, 85.7% of patients in the high-dose cohort showed complete ulcer closure. The Fast Track will expedite FDA interactions, facilitating faster review after successful Phase III completion, addressing a significant unmet medical need.
InflaRx N.V. (Nasdaq: IFRX) announced that its monoclonal anti-C5a antibody, vilobelimab, received orphan drug designation for treating pyoderma gangrenosum (PG) from both FDA and EMA. The company held a fruitful end-of-phase II meeting with the FDA to advance toward a Phase III program for PG. Additionally, a Type B meeting with the FDA is scheduled to discuss emergency use authorization for vilobelimab in severe COVID-19, while ongoing discussions with EMA are also in progress.
InflaRx N.V. (Nasdaq: IFRX) will present at the H.C. Wainwright Global Investment Conference from May 23-26, 2022, in Miami, Florida. The presentation is scheduled for May 25 at 10:30 AM EDT / 4:30 PM CEST, with a live stream available here. The company develops anti-inflammatory therapeutics targeting the complement system, aiming to address autoimmune diseases. A recording will be available on the InflaRx website post-event.
InflaRx N.V. (Nasdaq: IFRX) reported Q1 2022 results highlighting significant progress in clinical studies for vilobelimab, particularly in severe COVID-19 and pyoderma gangrenosum. Phase III results showed a 23.9% reduction in 28-day all-cause mortality for COVID-19 patients, while a Phase IIa study in pyoderma gangrenosum indicated a strong response. The company has halted development in hidradenitis suppurativa and ANCA-associated vasculitis. Financially, net loss rose to €14 million, with available funds of €99.3 million expected to support operations into H2 2024.
InflaRx (Nasdaq: IFRX) announced promising results from its Phase III PANAMO study of vilobelimab for mechanically ventilated COVID-19 patients. The treatment showed a 23.9% relative reduction in 28-day all-cause mortality compared to placebo (p=0.094), with a 43% reduction noted in a subgroup analysis of Western European patients (p=0.014). Although the primary endpoint wasn't statistically significant, further subgroup analyses indicated potential benefits, especially in patients with higher disease severity. The company plans to discuss results with regulatory authorities and will host a conference call to elaborate on the findings.
InflaRx N.V. announced a corrected FDA advice letter for its vilobelimab Phase III trial in hidradenitis suppurativa, clarifying primary endpoint measures. Positive results in Phase IIa studies for pyoderma gangrenosum and ANCA-associated vasculitis were reported, with topline data from the COVID-19 trial expected by the end of March. The company has €26.2 million in cash and €84.4 million in financial assets. Despite significant net losses, financial backing of €43.7 million from the German government supports ongoing trials.
InflaRx N.V. (Nasdaq: IFRX) announced a corrected advice letter from the FDA regarding its Phase III clinical trial of vilobelimab for hidradenitis suppurativa. The FDA now recommends using the modified HiSCR (m-HiSCR) as the primary endpoint instead of the previously suggested HiSCR. This change raises hopes for further development in HS. InflaRx is assessing strategic options for vilobelimab, especially after positive results in related conditions like pyoderma gangrenosum. The company plans to provide a pipeline development update in Q2 2022.
InflaRx N.V. (Nasdaq: IFRX) will present final data from its Phase IIa study on vilobelimab for pyoderma gangrenosum at the 2022 AAD Annual Meeting from March 25-29 in Boston. Dr. Afsaneh Alavi will deliver a late-breaker presentation on March 26, focusing on updated outcomes from the trial. Vilobelimab, a monoclonal anti-C5a antibody, has shown positive results in previous trials and is being developed for various conditions, including COVID-19 and cutaneous squamous cell carcinoma.