InflaRx Announces Presentation of New C5a and Vilobelimab (IFX-1) Data from Phase IIB SHINE Study at the 2021 Virtual European Hidradenitis Suppurativa Foundation Conference
- Significantly elevated baseline C5a levels occur in hidradenitis suppurativa (HS) patients
- Vilobelimab dose-dependently suppresses C5a levels over time accompanied by the previously reported reduction in inflammatory lesion counts and scores
- Data support continued development of vilobelimab in HS
JENA, Germany, Feb. 11, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the presentation of new data with vilobelimab (IFX-1), a first-in-class anti-C5a antibody, demonstrating significantly elevated baseline C5a levels in moderate and severe Hurley Stage II and III hidradenitis suppurativa (HS) patients compared to healthy volunteers. Data will be presented at the 10th Conference of the European Hidradenitis Suppurativa Foundation e.V. (EHSF) by Prof. Giamarellos-Bourboulis, from the ATTIKON University, Athens, Greece. The presentation, entitled, Complement split product C5a is elevated in moderate and severe hidradenitis suppurativa: clinical improvement by targeted therapy coming from the SHINE Study, will take place on February 11, 2021 at 11:30 am EST (5:30 pm CET).
The presentation will highlight the following content:
- C5a levels were significantly elevated in HS patients compared to healthy volunteers. C5a levels from the study were measured using a validated enzyme immunosorbent assay. Plasma was sampled from all patients before randomization and repeated at week 16. Median C5a (Q1/Q3) was 60.95 ng/ml (39.11/97.87) and 61.21 ng/ml (42.74/84.95) in Hurley stage II and III patients, respectively. In 20 healthy volunteers, C5a was 26.75 ng/ml (18.80/44.27).
- Elevated C5a levels in HS patients were dose-dependently suppressed by vilobelimab, and, within the high-dose treatment group (1200 mg q2w), suppressed to levels below normal median C5a levels of healthy humans at day 4 and week 16 upon initiation of treatment.
Additional baseline characteristics are being disclosed. Overall, 98 patients were classified as Hurley stage II and 79 as Hurley stage III. Differences of interest include the
median AN count levels at baseline (9.5 for the placebo group and 12.5 for the vilobelimab highest dose group).
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