InflaRx NV（IFRX）资讯与事件IFRXInflaRx NV

InflaRx Plans to Start Phase 2 Trials of Izicopan in 2027

InflaRx announced that it intends to begin two Phase 2 trials of izicopan in ANCA-associated vasculitis in 2027, with first data readout anticipated in 2028. The program is 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 study to demonstrate the ability to replace corticosteroids. InflaRx's proprietary research indicates izicopan's product profile supports the potential for significant market expansion, with an estimated peak sales potential in the range of $1.5B-$2B. Initial data from an investigator-initiated pilot study in atypical hemolytic uremic syndrome is anticipated in the second half of 2027, and InflaRx plans a pilot study in IgA nephropathy to be initiated in 2027, with early data in 2028. Cash, cash equivalents and marketable securities totaled 153.3M euros on September 30, expected to fund operations and clinical development through 2029. "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. C5aR inhibition has been clinically and commercially validated, and izicopan was specifically optimized to build on that foundation. Its rapid and sustained target inhibition, improved metabolic profile and potential for more convenient dosing support a compelling product profile. 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. 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," said Niels Riedemann, CEO and founder of InflaRx.

InflaRx Presents New Pre-Clinical Data on Izicopan in Renal Disease Models

InflaRx announced the presentation of new pre-clinical data on izicopan in renal disease models at the American Society of Nephrology's Kidney Week 2026, taking place in Denver, Colorado, October 21 - 25. The in vivo and in vitro data demonstrated that izicopan robustly inhibited C5aR-mediated inflammatory responses and provided renal protection, supporting its potential as a therapeutic candidate for complement-driven kidney diseases. Izicopan was evaluated in two established hamster models of kidney injury: renal ischemia-reperfusion injury, a model of acute kidney injury, and unilateral ureteral obstruction-induced nephropathy, a model of progressive renal injury and fibrosis. In both settings, oral izicopan significantly attenuated renal injury compared to vehicle-treated controls. IRI model: A single oral dose of izicopan, administered four hours before surgery, significantly reduced plasma levels of the renal function markers creatinine and blood urea nitrogen compared to vehicle. Izicopan also significantly improved the overall histopathological score of the kidney, as well as the infarction and necrotic area scores. UUO model: Izicopan, administered orally five hours before surgery and then once daily for 14 days, significantly reduced BUN levels and significantly improved the total H&E histopathological score compared to vehicle. Izicopan also showed a numerical trend toward reduced kidney fibrosis, as assessed by Masson's trichrome staining, and alpha-smooth muscle actin-positive cell counts. The structural modeling presented provides new insight into the differentiated molecular profile of izicopan. Compared with avacopan, izicopan preserves the key structural features required for high-affinity C5aR1 binding, while its trifluoromethyl substituent reduces interaction with CYP3A4/5, providing a molecular rationale for its low potential for clinically relevant time-dependent inhibition.

InflaRx Appoints Gabriela Alperovich as Global Head of Clinical Development

InflaRx announced the appointment of Gabriela Alperovich, MD, PhD, as Senior Vice President, SVP, & Global Head of Clinical Development, effective October 1, 2026. Alperovich joins InflaRx from CSL Vifor, where she served most recently as Executive Director, Global Clinical Lead for Cardiovascular and Renal.