The US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for an experimental drug that is being researched for its use as a treatment for ANCA-associated vasculitis. This means that researchers can now go ahead with the planned Phase II study of the drug, which is called IFX-1. The full article can be found here, at Globe Newswire.
About Vasculitis
Vasculitis is blood vessel inflammation. It is caused by the body’s immune system attacking healthy blood vessels, which leads to swelling and narrowing. Sometimes vasculitis is caused by infections or medicines, but often the cause is unknown. There are several forms of the condition that range in severity.
Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a subgroup of vasculitis, and AAV is itself a term used to describe a group of conditions that damage and inflame small and medium blood vessels. It is caused by neutrophils attacking the vessels and affects approximately 40,000 people in the US.
The Experimental Treatment
IFX-1 is being developed as a possible treatment for AAV. It is a monoclonal anti-complement factor C5a antibody that works by selectively blocking C5a. C5a is a protein that has been linked to the complement system (a part of the immune system) and the neutrophil attacks of the blood vessels that is a cause of AAV. So far, over 150 people have been dosed with IFX-1, and it is currently being investigated for the treatment of several different inflammatory conditions. More specific information about how the drug works can be found here.
The Upcoming Study
Following the FDA’s approval of the Investigational New Drug application, InflaRx N.V. can now go ahead with a planned Phase II clinical trial of IFX-1 for the treatment of AAV.
The study is expected to enrol around 36 patients across 20 U.S. sites. The trial will investigate the safety and efficacy of IFX-1 compared to a placebo in two dose regimens.
