InflaRx Highlights Izicopan Development Path and Commercial Opportunity in ANCA-Associated Vasculitis at Capital Markets Day
Key Highlights
- ➤InflaRx plans two Phase 2 AAV trials beginning in 2027, with first data expected in 2028
- ➤Izicopan AAV program targets renal involvement and corticosteroid replacement strategies
- ➤Izicopan estimated peak sales potential reaches $1.5-$2.0 billion
- ➤BDB-001 Phase 3 AAV trial in China expects data in 2H 2028
- ➤InflaRx reports €153.3 million cash, funding operations through 2029
Expert Statements
Niels Riedemann, Chief Executive Officer and Founder of InflaRx
“Our Capital Markets Day underscores our conviction that izicopan has the potential to become a differentiated therapy for patients with ANCA-associated vasculitis and other renal diseases.”
Niels Riedemann, Chief Executive Officer and Founder of InflaRx
“C5aR inhibition has been clinically and commercially validated, and izicopan was specifically optimized to build on that foundation.”
Niels Riedemann, Chief Executive Officer and Founder of InflaRx
“Its rapid and sustained target inhibition, improved metabolic profile and potential for more convenient dosing support a compelling product profile.”
Niels Riedemann, Chief Executive Officer and Founder of InflaRx
“Combined with our focused development strategy, we believe izicopan is well positioned to address important unmet needs in AAV and potentially establish a broader renal-disease franchise.”
Niels Riedemann, Chief Executive Officer and Founder of InflaRx
“We have benefited from the expert guidance of the distinguished clinicians and researchers who now comprise our AAV and renal disease Advisory Board, and we look forward to continuing to work closely with them as we advance izicopan in AAV and explore its potential across additional renal diseases.”
* With a goal of providing multiple data sets demonstrating differentiated efficacy and safety in multiple ANCA-associated vasculitis (AAV) settings, InflaRx intends to begin two Phase 2 trials in 2027, with first data readout anticipated in 2028 * Phase 2 AAV izicopan program expected to include a placebo-controlled randomized study in patients with renal involvement with site initiation in early 2027, as well as an open-label “all-comers” study to demonstrate the ability to replace corticosteroids * Initial data from an investigator-initiated open-label pilot study in atypical hemolytic uremic syndrome (aHUS) anticipated in the second half of 2027 * InflaRx planning pilot study in IgA nephropathy (IgAN) to be initiated in 2027, with expected early data readout in 2028 * InflaRx announces Advisory Board comprised of leading international experts in vasculitis, nephrology and immune-mediated renal disease * InflaRx proprietary research indicates izicopan’s product profile supports the potential for significant AAV market expansion, with an estimated peak sales potential in the range of $1.5 - 2.0 billion * BDB-001, a vilobelimab cell line-produced antibody targeting C5a and being evaluated by InflaRx’s collaborator, Staidson BioPharmaceuticals Co., Ltd. (Staidson), is currently in a Phase 3 trial in AAV in China, with data anticipated in 2H 2028 * Cash, cash equivalents and marketable securities totaled €153.3 million on September 30, 2026, expected to fund ongoing operations and clinical development through 2029 Jena, Germany, Nov. 03, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today is presenting its clinical development strategy and commercial vision for izicopan at the Company’s Capital Markets Day.
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