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InflaRx's Vilobelimab Hits Primary Endpoint Goal In Late-Stage ANCA-Associated Vasculitis Study

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InflaRx's Vilobelimab Hits Primary Endpoint Goal In Late-Stage ANCA-Associated Vasculitis Study
  • InflaRx NV (NASDAQ: IFRX) has announced topline results from its U.S. Phase 2 IXPLORE study evaluating vilobelimab in patients with anti-neutrophil cytoplasmic auto-antibody (ANCA)-associated vasculitis (AAV).
  • 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.
  • The primary endpoint of the study was to evaluate the safety of vilobelimab. Important efficacy parameters included response and remission rates based on the Birmingham Vasculitis Score (BVAS).
  • The IXPLORE safety study met its primary objective across all groups.
  • At baseline, patients in the higher dose vilobelimab group (800 mg) showed a higher BVAS of 17.5 (mean) / 16.5 (median) when compared to the baseline BVAS scores of the Standard Of Care (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 were 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.
  • The company says that the trial's sample size 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. More patients treated with SOC plus vilobelimab had clinical remissions at various time points throughout the study compared to SOC plus placebo.
  • Overall, no safety signal of concern could be detected in the study.
  • As previously reported, both Part 1 and Part 2 of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled. Data are expected by the end of 2021.
  • Price Action: IFRX shares are up 0.58% at $3.49 during the premarket session on the last check Wednesday.
 

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