- Phase III study to include a new primary endpoint, the modified HiSCR
- New primary endpoint and Phase III trial design to be discussed in detail at virtual R&D event on
February 3 rd - Phase III program to focus on HS patients with active draining tunnels and will start enrolling patients in Q2
JENA,
“We are excited to be able to move into pivotal testing with vilobelimab for the treatment of hidradenitis suppurativa, a debilitating and painful disease with limited treatment options,” said Dr.
InflaRx completed a Type A meeting with the
Virtual R&D event to highlight vilobelimab in HS, including Phase III study design
InflaRx will host a virtual R&D event on
About Vilobelimab (IFX-1):
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Over 300 people have been treated with vilobelimab in completed clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, ANCA-associated vasculitis and pyoderma gangraenosum, as well as other areas, including critical COVID-19 and cutaneous squamous cell carcinoma (cSCC).
About InflaRx N.V.:
Contacts:
InflaRx N.V.
Email: IR@inflarx.de
Tel: +1 917-338-6523
Email: inflarx@mc-services.eu
US: +1-339-832-0752
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms 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 in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our completed, planned and ongoing clinical trials of vilobelimab in hidradenitis suppurativa and the safety and efficacy results of those trials; the impact of the COVID-19 pandemic on the Company; the timing and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for our product candidates, including based on the modified HiSCR as the primary endpoint for the Company’s Phase III trial of vilobelimab in HS; our intellectual property position; our ability to develop commercial functions; expectations regarding clinical trial data; our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the
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