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

InflaRx NV 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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