InflaRx (IFRX) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Strategic focus and izicopan profile

• Renal disease is the current priority, with ANCA vasculitis targeted for the fastest path toward market; broader I&I indications such as hidradenitis suppurativa and CSU remain areas of interest.

• Izicopan is an oral C5aR inhibitor designed for faster, higher drug exposure; preclinical head-to-head studies showed nearly 2x efficacy at the same dose.

• Management cited potential advantages over avacopan in onset, coverage, safety, metabolite stability and convenience; izicopan does not block CYP3A4/5 and may allow once-daily dosing.

ANCA vasculitis program

• A double-blind, international, placebo-controlled study is starting, testing two doses on top of rituximab and a lower-end, widely accepted corticosteroid taper; design informed by FDA discussions.

• The study focuses on renal vasculitis, which affects 70%-80% of patients, includes very sick renal patients and aims to enable enrollment within days; planned enrollment is 18 months.

• Key proof-of-concept signals include early proteinuria reduction, eGFR, hematuria and possible time-to-renal-recovery or remission measures.

• FDA has consistently sought superiority efficacy evidence; phase II data will inform endpoint selection for phase III, with discussions planned as early as feasible and potential for a more concise pivotal trial.

• A separate open-label study will enroll all-comer patients needing remission induction to assess rapid corticosteroid reduction or replacement; management said additional evidence could reinforce the treatment’s patient value.

Other renal programs

• IgAN and IgAN with rapidly progressive glomerulonephritis are being prepared in parallel, with protocols and site assessments underway and rollout targeted for early 2027; initial data are expected in 2028.

• IgAN is intended to demonstrate activity; management sees oral dosing, rapid action and no vaccination requirement as potential advantages for combination or bridging use.

• IgAN RPGN affects about 5% of IgAN patients and is often excluded from trials; stabilizing renal function could support a distinct case in this high-unmet-need population.

• A small aHUS study at a specialist referral center will test the hypothesis that C5a/C5aR, rather than MAC, drives endothelial injury; first patient data may be available in 2027.