InflaRx has dosed the first patient in a Phase II trial to examine the safety and efficacy of IFX-1 for the treatment of patients with ANCA-associated vasculitis (AAV).
AAV is a rare and life-threatening autoimmune disease, estimated to affect around 40,000 and 75,000 people in the US and Europe respectively.
The Phase II trial features a randomised, double-blind, placebo-controlled setting and intends to include approximately 36 patients from around 20 sites in the US.
During the trial, InflaRx will compare two different dose regimens of IFX-1 to placebo.
Enrolled patients will be treated with the existing standard of care immunosuppressive therapy and high dose glucocorticoids.
The trial’s primary goal is to assess the safety of IFX-1, a monoclonal anti-complement factor C5a antibody.
Its additional objectives are efficacy and the generation of pharmacokinetic / pharmacodynamics (PK / PD) information.
The primary efficacy parameter of the trial is the response rate based on the Birmingham Vasculitis Score (BVAS).
“In clinical testing to date, IFX-1 has been shown to effectively and selectively control C5a activation.”
As part of the study, patients will be treated for 16 weeks and will be followed for an observation period of eight weeks.
InflaRx chief medical officer Othmar Zenker said: “With the launch of this Phase II trial, InflaRx now has studies underway in two orphan diseases with high unmet medical need (ANCA-associated vasculitis and hidradenitis suppurativa).
“In clinical testing to date, IFX-1 has been shown to effectively and selectively control C5a activation.
“Given the role that C5a is thought to play in amplifying the neutrophil-driven vessel wall inflammation and damage in AAV, we believe that IFX‑1 may have the potential to help patients suffering from this devastating disease.”
InflaRx is also currently developing IFX-1 for use in various inflammatory indications involving hidradenitis suppurativa and ANCA-associated vasculitis.