InflaRx provides a development update for Vilobelimab in
- Orphan Drug Designation granted for the treatment of pyoderma gangrenosum (PG) by the US FDA and EMA
- Productive end of phase II meeting with FDA for PG; ongoing dialogue regarding Phase III program design
- Type B meeting scheduled with FDA; ongoing dialogue with EMA for development in severe COVID-19
JENA, Germany, June 29, 2022 (GLOBE NEWSWIRE) — InflaRx NV (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapies by targeting the complement system, today provided an update on the development of its first in-class anti-C5a monoclonal antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19.
Vilobelimab has received orphan drug designation for the treatment of PG from the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. Additionally, the Company had a productive end-of-Phase II meeting with the FDA regarding its plans for a Phase III development program in PG. The FDA indicated its support for a randomized, controlled phase III development program at the meeting and offered to revise the study protocol, recognizing PG as a serious and rare disease. Based on the agency’s comments and recommendations, InflaRx is currently finalizing the design of a phase III trial and continues to engage with the agency on this.
Following encouraging Phase III results from the multinational randomized, placebo-controlled PANAMO study in patients with severe COVID-19 on mechanical ventilation announced earlier this year, InflaRx has requested a meeting with the FDA for guidance regarding a possible emergency use authorization submission. This was scheduled as a type B meeting for the start of the third quarter. In addition, the Company is in ongoing dialogue with the EMA regarding the next steps in the development of vilobelimab in patients with severe COVID-19 on mechanical ventilation in view of a possible approval dossier for this indication.
“We are pleased to see our development in pyoderma gangrenosum progress with the granting of Orphan Drug Designation by the FDA and EMA and with the fruitful discussions we have had with the FDA regarding our pivotal development program for this disease that is painful and debilitating for patients and can be life threatening,” said Professor Niels C. Riedemann, CEO and Founder of InflaRx. “We also look forward to further discussing our results of vilobelimab in severe COVID-19 with regulatory agencies in the United States and Europe to understand next steps toward possible licensing or approval for use of emergency. Our team believes that the robust survival results from our COVID-19 PANAMO study provide important scientific insights into the potential benefits of C5a inhibition even beyond COVID-19.
The company further reports that Jordan Zwick, Chief Strategy Officer, left InflaRx to pursue a business development opportunity. Mr. Zwick has agreed to continue to act as an advisor to the Company. Professor Riedemann commented: “Jordan has been a great member of our team and has contributed to important developments in society with his experience and his always positive energy. Although he will be missed by our team, we wish him the best in his future career and look forward to staying connected.
Vilobelimab is a first-in-class anti-human complement factor C5a monoclonal antibody, which strongly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves intact the formation of the membrane attack complex (C5b-9) as an important defense mechanism, which is not the case for the molecules blocking the cleavage of C5. Vilobelimab has been shown in preclinical studies to control tissue and organ damage caused by the inflammatory response by specifically blocking C5a as a key ‘enhancer’ of this response. Vilobelimab is believed to be the first anti-C5a monoclonal antibody introduced into clinical development. Vilobelimab has been shown to be well tolerated in clinical trials in different disease settings. Vilobelimab is currently in development for various indications, including pyoderma gangrenosum and severe COVID-19. The Company recently reported positive Phase IIa results in PG and encouraging Phase III results in mechanically ventilated COVID-19 patients. Vilobelimab is also in phase II development for patients with cutaneous squamous cell carcinoma.
About InflaRx NV
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary technology to discover and develop potent, specific first-in-class or best-in-class C5a and C5aR inhibitors. C5a and C5aR complements are potent inflammatory mediators implicated in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007 and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For more information, please visit www.inflarx.com.
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This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by words such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”. , “could”, “intend”, “target”, “project”, “believe”, “estimate”, “predict”, “potential” or “continue” and similar expressions. Forward-looking statements appear at several places in this release and may include statements regarding our intentions, beliefs, projections, outlook, analyzes and current expectations regarding, among other things, our ongoing and planned preclinical development and clinical trials. , including the development of vilobelimab to treat pyoderma gangrenosum (PG) and severe COVID-19, and associated communications with the FDA; the impact of the COVID-19 pandemic on us; the timing and our ability to commence and conduct clinical trials; potential results of current or potential future collaborations; our ability to make regulatory filings, obtain positive advice from regulatory authorities and obtain and maintain regulatory approvals for our product candidates; our position on intellectual property; our ability to develop business functions; expectations regarding clinical trial data; decisions regarding the strategic direction of our business; our results of operations, cash requirements, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; trends that may affect the industry or us; our status as an emerging growth company and/or foreign private issuer; and the risks, uncertainties and other factors described under “Risk Factors” in InflaRx’s periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to differ materially from the results, future performance or achievement expressed or implied by the forward-looking statements. In view of these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we undertake no obligation to update these forward-looking statements, even if new information becomes available in the future. except as required by law. .