InflaRx N.V. - IFRX STOCK NEWS

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.

InflaRx N.V. (Nasdaq: IFRX) announced a pause in its Phase III trial for vilobelimab in treating hidradenitis suppurativa (HS) after receiving unexpected feedback from the FDA. The FDA recommended using the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint, differing from prior guidance where InflaRx proposed a modified HiSCR. This new feedback emerged almost three months post-protocol submission. The FDA did not issue a clinical hold, and InflaRx plans to clarify the FDA's advice moving forward.

InflaRx (Nasdaq: IFRX) announced the continuation of a Phase II clinical trial for vilobelimab, an anti-inflammatory drug, in combination with pembrolizumab for cutaneous squamous cell carcinoma (cSCC). Three patients have safely completed 36 days of the first dosing cohort, prompting the Steering Committee to open enrollment for the second dosing cohort. Ongoing enrollment in vilobelimab monotherapy also shows no safety concerns. The trial aims to evaluate the drug's safety and effectiveness, with interim results expected in Q1 2023.

InflaRx N.V. (Nasdaq: IFRX) will present at the 11th Annual SVB Leerink Healthcare Conference, scheduled for February 14-18, 2022. CFO Thomas Taapken and Chief Strategy Officer Jordan Zwick will engage in a fireside chat on February 17 at 10:40 am EST. The event will be accessible via a live audio webcast on the InflaRx website. InflaRx focuses on targeting the complement system to develop anti-inflammatory therapeutics, specializing in C5a and C5aR inhibitors for various autoimmune diseases.

InflaRx N.V. (Nasdaq: IFRX) announced the initiation of regulatory discussions for its Phase I program concerning INF904, a novel oral small molecule inhibitor targeting C5aR. The company plans to commence the first-in-human study in the latter half of 2022. Recently granted a composition of matter patent for INF904, the drug has demonstrated strong anti-inflammatory effects in preclinical studies, showcasing a favorable safety profile and improved drug interactions compared to existing inhibitors. INF904 aims to treat chronic autoimmune and inflammatory diseases with ease of oral administration.

InflaRx N.V. (Nasdaq: IFRX) has announced its participation in key investor conferences, including the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, and the H.C. Wainwright BioConnect Conference starting January 10, 2022. The company will also host a virtual R&D event on February 3, 2022, focused on vilobelimab for Hidradenitis Suppurativa, detailing study design and endpoints for its Phase III trial. InflaRx aims to develop innovative anti-inflammatory therapeutics targeting the complement system.

InflaRx N.V. (Nasdaq: IFRX) announced the initiation of a Phase III trial for vilobelimab targeting hidradenitis suppurativa (HS) patients with active draining tunnels. The study will use a new primary endpoint, the modified HiSCR, to assess the reduction of inflammatory nodules, abscesses, and draining tunnels. Patient enrollment is set to commence in Q2 2022, following FDA support for the trial design. A virtual R&D event scheduled for February 3, 2022, will provide further insights into the study. Over 300 individuals have previously received vilobelimab in clinical trials.

InflaRx (Nasdaq: IFRX) announced encouraging results from its Phase II IXCHANGE study of vilobelimab in ANCA-associated vasculitis (AAV). The study showed that vilobelimab matched the efficacy of standard glucocorticoids while significantly reducing their usage and associated toxicity. In total, 57 patients participated in the trial, demonstrating high clinical response rates across treatment groups. Notably, vilobelimab alone had the least treatment-emergent adverse events. The company plans to consult regulatory authorities to discuss the next steps for vilobelimab's development.