The first patient has been dosed in InflaRx‘s ongoing European Phase 2 clinical trial testing the safety and efficacy of its IFX-1 investigational therapy for the treatment of ANCA-associated vasculitis (AAV), the company announced.
IFX-1, the company’s lead drug candidate, is a first-in-class antibody designed to target and block the activity of the complement activation C5a protein. This protein is part of the complement system — a set of more than 30 blood proteins that form part of the body’s immune defenses — that is thought to be involved in the overactivation of the immune system in AAV.
InflaRx in July 2018 announced the launch of a Phase 2 trial (NCT03712345) in the U.S. to assess the effectiveness of IFX-1 in AAV patients. That followed the approval of the company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration.
Then, by the end of 2018, InflaRx confirmed the launch of a similar Phase 2 trial in Europe, after receiving approval from European authorities.
The European trial is called IXchange (NCT03895801). A multicenter, randomized, double-blind, placebo-controlled, Phase 2 trial, IXchange is evaluating the safety and efficacy of IFX-1, compared with a placebo, in patients with moderate to severe AAV receiving standard care immunosuppressive therapy, either with Rituxan (rituximab) or cyclophosphamide.
The trial, which is still recruiting, is expected to enroll approximately 80 AAV patients from 60 clinic sites across 12 European countries and Russia.
The study will be divided into two parts. During Part 1, participants will be randomly assigned to receive either IFX-1 plus a small dose of glucocorticoids, or a placebo plus a standard dose of glucocorticoids. Glucocorticoids are a steroid that can reduce inflammation.
Once Part 1 is completed, an independent monitoring committee will be responsible for reviewing its safety and efficacy data, and will decide whether the trial should proceed to Part 2. The main goal of the second part will be to assess whether the effects of treatment with IFX-1 alone are identical to those obtained with IFX-1 in combination with glucocorticoids.
The trial’s primary endpoint will be to determine the percentage of patients achieving a clinical response, defined as attaining at least a 50% reduction in the Birmingham Vasculitis Activity Score (BVAS) – a measure of disease activity – after 16 weeks of treatment.
Secondary endpoints include treatment safety assessments, percentage of patients achieving clinical remission, and evaluation of the Vasculitis Damage Index. The investigators also will analyze glucocorticoid toxicity, IFX-1 plasma levels, multiple disease biomarkers — including the glomerular filtration rate to assess kidney function — and patient-reported outcomes.
“With the treatment of the first patient in the IXchange study, we now have two Phase 2 clinical studies with IFX-1 in AAV ongoing — one in Europe and one in the US,” Othmar Zenker, MD, chief medical officer at InflaRx, said in a press release. “We are excited to continue our evaluation of both the effectiveness of IFX-1 compared to standard of care, as well as the potential of IFX-1 to replace glucocorticoids in treating this devastating disease.”
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