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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

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·6 min read
In this article:
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  • 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).

These findings confirm earlier reported results on elevated C5a levels in HS patients and on the ability of vilobelimab to reduce such levels in HS patients. Together with the previously reported data on vilobelimab´s ability to reduce inflammatory lesions and scores, these data further stress the potential important role played by C5a in the pathogenesis of HS. The results support the company´s plan to continue development of vilobelimab in HS.

About Hidradenitis Suppurativa (HS):

HS is a chronic debilitating systemic skin disease which results in painful inflammation of the hair follicles, typically in the armpit, groin and genitalia regions. HS patients suffer primarily from pain driven by inflamed nodules and abscess formation and significant discomfort resulting from the constant formation of pus, particularly in the areas described above, leading to social isolation. HS is typically present after adolescence and often develops into a life-long debilitating chronic disease. In the United States, up to 200,000 patients are affected annually with moderate to severe disease (Hurley stages II to III), with a current increase in recognition and diagnoses being expected and discussed amongst key opinion leaders. In Europe, the number of affected patients is considered to be higher, with a trend of more cases of HS in countries with overall warmer climates. The standard of care for HS patients includes antibiotic treatment, which often only provides temporary symptomatic relief. In some cases, patients also undergo surgery. The only approved biological drug in this indication for moderate to severe HS patients is an anti-TNF-alpha monoclonal antibody.

About Vilobelimab (IFX-1):

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum, cancer and severe COVID-19.

About InflaRx N.V.:

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information please visit www.inflarx.com.


InflaRx N.V.

Jordan Zwick – Chief Strategy Officer
Email: jordan.zwick@inflarx.de
Tel: +1 917-338-6523

MC Services AG

Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +1-339-832-0752


This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned pre-clinical development and clinical trials; the impact of the COVID-19 pandemic on the Company; the timing and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; our ability to develop commercial functions; expectations regarding clinical trial data; our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.