InflaRx publishes Phase 1 izicopan data, backing Capital Markets Day plans for AAV

InflaRx N.V. announced on November 6, 2026 that peer-reviewed Phase 1 data for izicopan, its oral C5a receptor inhibitor formerly called INF904, have been published in Clinical Pharmacology in Drug Development, reporting results from the company's single and multiple ascending dose study in 86 healthy participants.¹ The company said the positive results had been previously announced.¹

The drug was tolerated across single doses from 3 mg up to 240 mg and across three multiple-dose regimens given over 14 days, with only mild or moderate adverse events, no dose-dependent safety pattern, no serious adverse events, and no clinically relevant changes in lab values, vital signs, ECGs, telemetry or physical exams.¹ Pharmacodynamic testing showed rapid, dose-related suppression of C5a receptor signaling, with strong blockade of an inflammatory marker maintained through the dosing period in most groups tested, according to the company. Plasma exposure rose with dose across the single-dose range, with peak concentrations reached roughly 3.5 to 6 hours after dosing, and key exposure measures were generally proportional to dose in that portion of the study.¹

This publication follows InflaRx's November 3, 2026 Capital Markets Day, where the company said it intends to begin two Phase 2 trials in 2027 targeting ANCA-associated vasculitis (AAV), with first data readout anticipated in 2028. One trial is a placebo-controlled study in AAV patients with renal involvement, with site initiation expected in early 2027; the other is an open-label trial testing whether izicopan can replace glucocorticoid treatment during remission induction.

InflaRx has cited an independent commercial assessment estimating izicopan's peak sales potential at $1.5 to $2.0 billion.² As of September 30, 2026, cash, cash equivalents and marketable securities totaled €153.3 million, which the company said is expected to fund operations through 2029.²