InflaRx (IFRX) CMD 2026 summary

Izicopan profile

• Oral C5aR inhibitor; Phase 1/2a data showed rapid exposure and deep C5a blockade. At 30 mg once daily, ≥90% blockade was reached by day 6; AAV dose and regimen remain to be set.

• Cross-study comparison, not head-to-head: reported ~10x AUC and ~3x Cmax versus avacopan at equal doses.

• 197 people dosed with no safety signals of concern or liver-enzyme elevations; potential for once-daily dosing may reduce pill burden.

• GSH-trapping assays showed >100x lower early reactive-metabolite signal; in vitro data indicated no time-dependent CYP3A4/5 inhibition and high metabolic stability.

• C5aR targeting leaves upstream and terminal complement pathways intact, with potential vaccine and CYP-related medication advantages.

AAV opportunity and development

• Randomized, double-blind Phase 2 in renal AAV planned to start sites in early 2027: izicopan 30 mg or 60 mg BID versus placebo, on rituximab and standard glucocorticoid taper; ~35 patients per arm, 12 months’ treatment and key readout at week 24.

• Measures include BVAS remission, eGFR, proteinuria and hematuria; enrollment allows eGFR below 20, with substantial renal involvement expected.

• Separate open-label Phase 2 planned for 2027 in newly diagnosed or relapsing AAV, testing glucocorticoid replacement through staged rapid taper; ~30 patients, with first data expected in 2028.

• FDA discussions informed trial design; further development and potential transition to registrational studies remain under evaluation.

• Peak-sales estimates include a $1.65bn AAV base case and an independent $1.5–2.0bn global estimate; physician research found 65–70% stated preference share in severe renal AAV if avacopan exits.

Broader renal development and milestones

• Open-label IgAN and rapidly progressive IgAN pilot planned for 2027, with initial data targeted for 2028; proteinuria and eGFR are exploratory measures.

• Investigator-initiated aHUS pilot plans 6–8 patients, prioritizes safety and TMA response, and has eculizumab rescue available; initial data targeted for 2H 2027.

• Staidson’s BDB-001, a vilobelimab anti-C5a antibody licensed in China, is in a Phase 3 AAV trial; data expected in 2H 2028.

• Izicopan China PK bridging study expected to report in H1 2027 to facilitate enrollment in China.