In a recent news release, biotechnology company InflaRx N.V. announced that the first participant had been dosed with vilobelimab in a Phase 3 clinical trial. Within the trial, researchers are hoping to determine how safe and effective the treatment is for people living with ulcerative pyoderma gangrenosum, a rare inflammatory skin disorder. There are no existing treatments that are disease-specific; instead, people with pyoderma gangrenosum typically manage their condition through wound care, corticosteroids, pain medication, or therapies like Cellcept, Remicade, or Protopic.
Researchers want to know if vilobelimab could effectively treat pyoderma gangrenosum and bring relief to those affected. Vilobelimab is an anti-C5a monoclonal antibody that blocks C5a activity. C5a is part of the complement system, which plays a role in inflammation and immune response. By blocking C5a, the treatment slows or stops severe inflammatory responses in the body; this has been shown in preclinical studies. Vilobelimab has received both Fast Track and Orphan Drug designations by the FDA.
Within this study, which will enroll an estimated 30 participants, researchers will track the drug’s safety, efficacy, and tolerability. Participants will be split into two groups: one which receives corticosteroids and a placebo, and the other which receives 2,400mg vilobelimab bi-weekly with corticosteroids. The primary endpoint is ulcer closure (wound healing).
The Key Facts: Pyoderma Gangrenosum
So what exactly is pyoderma gangrenosum? The Mayo Clinic describes pyoderma gangrenosum as:
a rare condition that causes large, painful sores (ulcers) to develop on your skin, most often on your legs.
While doctors typically consider this to be an autoimmune condition, the underlying cause is unknown. People with this condition are not infectious; ulcers cannot be transmitted to anybody else. This condition is most common in people between ages 40 to 60 (though it can happen in pople of all ages) and in those with other conditions such as rheumatoid arthritis, inflammatory bowel disease, acute myeloid leukemia, and other myeloproliferative disorders.
Pyoderma gangrenosum often manifests as a small red or purple bump/pustule on the skin. As it progresses, it becomes a large, painful open sore with a blue or violet border. Additional symptoms and complications associated with this condition may include:
- General malaise
- Joint pain
- Localized tenderness
- Loss of mobility