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) announced promising results from its Phase IIa study of vilobelimab for Pyoderma Gangraenosum (PG). In the highest dose cohort, 85.7% of patients demonstrated clinical remission, with no dose-related adverse events reported. The study enrolled 19 patients, showing significant efficacy at various dosages. InflaRx plans to seek FDA guidance for a pivotal program based on these results. A conference call will be held today at 8:30 am EDT to discuss this data further.
InflaRx N.V. (Nasdaq: IFRX) has been awarded a grant of up to EUR 43.7 million by the German government to support the development of vilobelimab for COVID-19 treatment. The initial tranche of EUR 25.8 million will reimburse 80% of specified expenses related to clinical development and manufacturing. The grant aims to expedite vilobelimab's development and secure manufacturing capacity in Germany. The ongoing Phase III study is fully enrolled, with top-line results expected in Q1 2022.
InflaRx N.V. (Nasdaq: IFRX) has completed enrollment in the Phase III portion of its vilobelimab study, which targets severe COVID-19 patients. The study enrolled 369 patients in multiple countries, including Europe and South America. Topline results are anticipated in Q1 2022, focusing on 28-day all-cause mortality among other endpoints. The Phase II part showed a mortality rate of 13% in the vilobelimab arm versus 27% in the control group. Vilobelimab is a promising anti-C5a antibody aimed at treating various inflammatory conditions.
InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company, announces that CEO Prof. Niels C. Riedemann will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on demand from 7:00 AM EDT / 1:00 PM CET on September 13, 2021. A webcast of the event can be accessed for 90 days on the InflaRx website in the Investors section.
InflaRx focuses on developing anti-inflammatory therapeutics targeting the complement system, specifically through its proprietary anti-C5a technology.
InflaRx (Nasdaq: IFRX) has received FDA feedback from its Type A meeting, supporting a pivotal development program for vilobelimab in treating moderate to severe Hidradenitis Suppurativa (HS). The FDA acknowledged that targeting pain and draining lesions represents a clinically meaningful outcome, leading to a new primary efficacy endpoint. The company aims to submit the updated study protocol in Q4 2021, following FDA approval. With a significant need for new treatments, vilobelimab is positioned as a potential solution for HS patients suffering from debilitating symptoms.
InflaRx N.V. (Nasdaq: IFRX) announced encouraging results from its Phase IIa study of vilobelimab in Pyoderma Gangraenosum (PG), with four out of ten evaluable patients showing a clinical response at day 99. Three patients achieved complete closure of their target lesions, with treatment being well tolerated and no significant adverse events during dose escalation. The study enrolled 19 patients, with doses of vilobelimab ranging from 800mg to 2400mg. The ongoing study aims to assess vilobelimab's efficacy and safety further, especially in the higher dose cohort.
InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company, will present at the BTIG Virtual Biotechnology Conference on August 10, 2021. The event will feature a fireside chat with CEO Prof. Niels C. Riedemann, discussing the company's pipeline and upcoming catalysts at 9:00 am EDT. InflaRx is focused on developing first-in-class inhibitors of C5a, a key inflammatory mediator involved in various autoimmune diseases. Founded in 2007, the company operates in Germany and the USA.
InflaRx announced significant progress in its clinical trials and a financial update for Q2 2021. The severe COVID-19 trial has enrolled 299 patients, with an independent data monitoring committee recommending continuation. A Type A meeting has been requested with the FDA regarding the Phase III study for Hidradenitis Suppurativa. The first patients have been dosed in a Phase II trial for Cutaneous Squamous Cell Carcinoma. As of June 30, 2021, financial assets total approximately €127.5 million, though the company reported a net loss of €20.9 million for the first half of 2021.
InflaRx N.V. (Nasdaq: IFRX) will virtually present at the Raymond James Human Health Innovation Conference from June 21-23, 2021. Prof. Niels C. Riedemann, CEO and Founder, will engage in a fireside chat on June 23 at 10:00 am EDT, discussing the company's pipeline and forthcoming catalysts. A live webcast will be available on InflaRx's website, with a replay accessible post-event. The company specializes in developing anti-inflammatory therapeutics targeting the complement system, specifically using its proprietary anti-C5a technology.
InflaRx N.V. (Nasdaq: IFRX) has initiated a Phase II clinical trial evaluating vilobelimab, both as a standalone treatment and in combination with pembrolizumab, for patients with PD-1 or PD-L1 inhibitor-resistant locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). The trial aims to enroll around 70 patients and assess the safety and anti-tumor efficacy of vilobelimab. Given the poor prognosis of advanced cSCC, the development of vilobelimab, a monoclonal antibody targeting C5a, could provide vital treatment options for patients.