The Food and Drug Administration (FDA) has granted Fast Track designation to vilobelimab for the treatment of ulcerative pyoderma gangrenosum (PG), a rare skin disorder characterized by chronic painful skin ulcers.

Vilobelimab is a first-in-class anti-human complement factor C5a monoclonal antibody. The investigational treatment works by targeting C5a with high selectivity. By blocking C5a-induced proinflammatory effects such as neutrophil activation and cytokine generation, vilobelimab is expected to control local skin inflammation and tissue damage in patients with PG.

The designation is supported by data from a multicenter, proof-of-concept phase 2a study ( Identifier: NCT03971643) that evaluated the efficacy and safety of vilobelimab at 3 doses (800mg, 1600mg, or 2400mg via intravenous infusion), in 19 adults with PG over 24 weeks. Findings showed that 6 out of 7 patients (85.7%) in the high dose cohort achieved complete target ulcer closure and treatment response.

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“We are pleased that our development in pyoderma gangrenosum has been designated Fast Track by the FDA shortly after receiving the Orphan Drug designation, recognizing PG as serious condition with high unmet medical need and vilobelimab as promising potential future treatment option,” said Prof. Niels C. Riedemann, CEO and Founder of InflaRx.

Vilobelimab is also being investigated as a treatment for severe COVID-19 pneumonia ( Identifier: NCT04333420), as well as for cutaneous squamous cell carcinoma ( Identifier: NCT04812535).


InflaRx receives FDA Fast Track designation for treatment of ulcerative pyoderma gangrenosum. News release. InflaRx N.V. Accessed July 6, 2022.

This article originally appeared on MPR