InflaRx N.V.

AAV development path

To leverage the strengths of izicopan’s pharmacologic properties against the substantial unmet need that exists in AAV, InflaRx’s izicopan AAV program is targeting the generation of multiple differentiating efficacy and safety data sets in a variety of AAV settings with different strategic goals.

InflaRx expects trial site initiation to begin in early 2027 in a randomized, double-blind, placebo-controlled Phase 2 trial evaluating two izicopan doses on top of standard of care, including rituximab and GC tapering. The current design contemplates approximately 35 patients per arm and 12 months of treatment, with key data readouts occurring at 24 weeks. Efficacy assessments are expected to include disease remission, renal function, proteinuria, hematuria and renal recovery endpoints alongside safety and other efficacy assessments, as well as GC use. The enrollment period is expected to be approximately 18 months. The trial design will focus on AAV patients with defined renal involvement (renal vasculitis) and has been optimized to detect potential efficacy signals of izicopan on renal function and renal injury recovery when compared to placebo treatment.

In addition, InflaRx intends to initiate an open-label Phase 2 trial in 2027 in newly diagnosed or relapsing AAV patients in need of remission induction therapy, exploring safety and efficacy in patients when replacing GC treatment. For this, a two-stage design is planned in which a rapid taper of GC is applied in Stage 1, during remission induction therapy (e.g., in conjunction with rituximab). Upon safety assessment, a planned complete replacement strategy will be explored in Stage 2. First data from this study are expected in 2028. The trial will assess the ability of izicopan to replace GC treatment during remission induction without impacting patient safety.

This open-label trial is informed by a recently conducted Phase 1/2 trial with BDB-001, a vilobelimab cell line-produced antibody targeting C5a licensed to the Company’s Chinese partner, Staidson, in which a complete GC replacement at enrollment was successfully conducted and yielded numerically favorable remission rates when compared to the open-label control arm. The trial is further supported by external market research indicating the value that physicians ascribe to data demonstrating the ability to minimize GC use in AAV.

As currently planned, the randomized placebo-controlled Phase 2 study has been informed by first interactions with the FDA and is designed to evaluate efficacy signals focusing on renal and disease activity endpoints. InflaRx continues to evaluate options to transition as quickly as possible into registrational phase.

InflaRx continues to anticipate engaging with EMA regarding both vilobelimab and izicopan to likewise evaluate the regulatory path for InflaRx to the AAV market in that geography.

In addition, BDB-001, a vilobelimab cell line-produced antibody targeting C5a which is being evaluated by InflaRx’s collaborator Staidson, is currently in a Phase 3 trial in AAV in China, with data anticipated in 2H 2028.