InflaRx will soon launch a Phase 2 clinical trial in Europe to assess the safety and effectiveness of IFX-1 — an investigational inhibitor of the complement system — in patients with ANCA-associated vasculitis (AAV).
Now that European authorities have approved it, the randomized, placebo-controlled Phase 2 trial is expected to recruit approximately 80 AAV patients at roughly 60 sites in Europe. It will mainly evaluate the safety and effectiveness of IFX-1 in two parts.
In the first part, patients will receive IFX-1 along with a reduced dose of glucocorticoids, and the results will be compared with patients treated with a standard dose of glucocorticoids only.
In the second part, the researchers will evaluate IFX-1’s performance when administered alone versus a standard dose of glucocorticoids.
Participants in the trial will continue to receive the current standard-of-care immunosuppressive therapy, either with Rituxan (rituximab) or cyclophosphamide. The trial is expected to begin by April 2019.
“We are pleased to be able to move forward with the second phase II study in AAV with IFX-1. AAV is an orphan disease with high unmet medical need,” Othmar Zenker, MD, chief medical officer of InflaRx, said in a press release.
The protein plays a role in the progression of a wide variety of autoimmune and other inflammatory diseases when produced in higher-than-normal levels.
C5a is thought to amplify the harmful immune response that is characteristic of AAV, playing a key role in vessel inflammation. IFX-1 neutralizes C5a without affecting the normal immune response to infections.
In July 2018, InflaRx launched a Phase 2 trial testing IFX-1 in AAV patients in the Unites States, after the U.S. Food and Drug Administration approved the company’s investigational new drug application.
The trial (NCT03712345), currently recruiting participants, is assessing the safety and effectiveness of two different dose regimens of IFX-1 versus a placebo in patients also receiving the current standard of care.
“Together with the first study already ongoing in the US, we have initiated a state-of-the-art phase II program to evaluate the impact of IFX-1 on this often life-threatening disease,” Zenker said.