Jena, Germany,?May 11,?2021?? InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system,?announced?today positive topline results from its U.S. Phase II IXPLORE study with vilobelimab in patients with anti-neutrophil cytoplasmic auto-antibody (ANCA)-associated vasculitis, or AAV.

?ANCA-associated vasculitis is an organ and life-threatening disease. Although current treatments for AAV are quite helpful in many patients, there are still unmet needs for fast-acting, effective, and safe treatments and alternatives to the regular use of high-dose glucocorticoids,? said Dr. Peter A. Merkel, Chief of Rheumatology and Professor of Medicine at the University of Pennsylvania. ?Research suggests C5a has an important role in the pathogenesis of AAV, and blockade of C5a offers the opportunity to address several of these unmet needs.??The results of the IXPLORE trial show C5a blockade by vilobelimab is safe and well tolerated when added to standard of care therapy for AAV.??These results support the continued study of vilobelimab for the treatment of AAV.?

?We are pleased to report that vilobelimab was safe and well tolerated in combination with standard of care for patients with ANCA-associated vasculitis in the U.S. IXPLORE Phase II trial,? said Dr. Korinna Pilz, Global Head of Clinical Research and Development. ?We are looking forward to our EU IXCHANGE Phase II trial results later this year where we are further evaluating the potential efficacy of vilobelimab alone compared to a standard dose of glucocorticoids. The results from these two trials will provide us good insight to plan our next development steps in this important indication.?

U.S. Phase II IXPLORE Study Design and Topline Results

The randomized, double-blind, placebo-controlled Phase II study enrolled 19 patients in the U.S. (NCT 03712345). The study compared two different dose regimens of vilobelimab to placebo. All patients received current standard of care immunosuppressive therapy and high dose glucocorticoids (SOC). The primary endpoint of the study was to evaluate the safety of vilobelimab, as this was the first time the drug was being administered to patients with AAV in the U.S. Important efficacy parameters included response and remission rates based on the Birmingham Vasculitis Score (BVAS), a validated and well-established score in AAV. Patients were randomized into three groups:

• SOC plus placebo;
• SOC plus 400 mg vilobelimab q2w; and
• SOC plus 800 mg vilobelimab q2w

Patients were treated for 16 weeks (including a fractionated loading dose at days 4 and 8) followed by an observation period of 8 weeks.

The IXPLORE safety study met its primary objective: Across all groups, a similar number of patients experienced one or more treatment-emergent adverse events (TEAEs).

• TEAEs:
  • 5 of 6 patients (SOC plus placebo)
  • 7 of 7 patients (SOC plus vilobelimab 400 mg)
  • 6 of 6 patients (SOC plus vilobelimab 800 mg)

In addition, a similar number of patients experienced TEAEs rated as drug-related by investigators:

• Any drug-related TEAE:
  • 3 of 6 patients (SOC plus placebo)
  • 3 of 7 patients (SOC plus vilobelimab 400 mg)
  • 2 of 6 patients (SOC plus vilobelimab 800 mg)

Overall, no safety signal of concern could be detected in the study, as observed TEAEs are reflective of the disease and SOC treatment.

At baseline, patients in the higher dose vilobelimab group (800 mg) showed a higher Birmingham Vasculitis Activity Score (BVAS) of 17.5 mean / 16.5 median, when compared to the baseline BVAS scores of the SOC group (13.8 mean / 13.5 median) and the 400 mg vilobelimab group (13.1 mean / 12.0 median).

The IXPLORE study was not powered to show statistical significance on efficacy endpoints; however, clinical response and remission for each treatment group was measured at week 16 as secondary efficacy endpoints using the BVAS. The proportion of patients achieving a clinical response was defined as a 50% reduction in BVAS at week 16 (and no worsening in any body system) compared to baseline, and clinical remission was defined as BVAS=0.

Although the sample size of the trial was small and it is difficult to interpret results not powered to show statistical significance, patients across all three treatment groups demonstrated a strong response at week 16, and more patients treated with SOC plus vilobelimab had clinical remissions at various timepoints throughout the study compared to SOC plus placebo:

FORWARD-LOOKING STATEMENTS

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