InflaRx (IFRX) Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary

Key data highlights

• Presented positive efficacy and safety data for an oral C5aR inhibitor in HS and CSU, with consistent improvement across groups and strong patient-reported outcomes, especially in pain and quality of life.

• In HS, high-dose groups showed the most severe baseline characteristics and the greatest efficacy, with rapid and durable reductions in inflammatory lesions, including draining tunnels.

• In CSU, the 60 mg dose demonstrated clear, placebo-differentiated effects, particularly in more severe patients, with sustained improvement over eight weeks.

• The drug showed a favorable safety profile in over 180 patients, with no dose-limiting toxicity observed in up to nine months of non-human primate studies.

• Off-drug data indicated sustained or deepening responses, likely due to the drug’s mechanism and tissue distribution.

Differentiation and pharmacokinetics

• The oral C5aR inhibitor achieves much faster and higher plasma exposure than Avacopan, reaching or exceeding steady-state levels within the first week.

• High-dose (120 mg) group in HS outperformed lower doses, with no current plans to go higher due to already strong efficacy and safety.

• PK profiles in CSU and HS are similar, though HS patients have higher BMI, affecting volume distribution.

• The drug’s rapid onset and tissue penetration may explain the faster and more pronounced clinical effects compared to Avacopan.

Development plans and regulatory strategy

• Preparations are underway for a larger phase 2b study in HS, likely including the 120 mg dose, with plans for a 12–16 week trial and a probable open-label extension.

• Separate regulatory interactions are planned for HS (dermatology division) and CSU (allergy division), with HS prioritized.

• Further studies in CSU are being considered, especially for more severe patients, to explore the drug’s potential in this indication.