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 - Seite 2

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.