InflaRx has completed patient enrolment in a Phase IIb clinical trial to evaluate IFX-1 in the treatment of moderate to severe hidradenitis suppurativa (HS).
HS is a chronic inflammatory skin disease that causes abscesses and scarring.
Investigational antibody IFX-1 is being developed to block the human complement factor C5a, an inflammatory mediator known to be associated with multiple autoimmune diseases.
The randomised, double-blind, placebo-controlled trial is designed to investigate the safety and efficacy of four different doses of IFX-1 over 16 weeks.
Primary endpoint of the trial is dose-response signal measured using the hidradenitis suppurativa clinical response (HiSCR) score at week 16.
“Our goal with this Phase IIb study is to determine the optimal dose regimen, as well as assess both long-term efficacy and safety of IFX-1.”
Conducted across 38 sites in North America and Europe, the study will also assess objectives such as the tolerability of IFX-1, additional efficacy and patient-reported outcome parameters.
The dosing period will be followed by a 28-week open-label extension phase to evaluate long-term efficacy and safety.
InflaRx chief medical officer Othmar Zenker said: “Following the promising results we observed in our earlier trial with IFX-1 in hidradenitis suppurativa, our goal with this Phase IIb study is to determine the optimal dose regimen, as well as assess both long-term efficacy and safety of IFX-1 in patients with this disease.”
So far, IFX-1 has been studied in three Phase II trials. In pre-clinical studies, the drug candidate displayed a capability to block C5a and control the tissue and organ damage caused by inflammatory response.
InflaRx expects to report top-line results from the Phase IIb trial in the first half of next year.