InflaRx announces initial phases of IFX-1 clinical trials in severe COVID-19 induced pneumonia

InflaRx has announced the start of the global Phase III part of its Phase II/III trial with IFX-1 in severe COVID-19 induced pneumonia with the initiation of the first clinical site in the Netherlands. In parallel, the German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved the Phase III clinical trial in Germany.

The randomized, double-blinded and placebo-controlled Phase III part of the Phase II/III trial plans to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia across sites in the US, EU, South America and other regions. Patients will be randomized 1:1 to receive either IFX-1 or placebo; all patients will receive standard of care.
The primary endpoint will be 28-day all-cause mortality; key secondary endpoints will include assessment of organ support and disease improvement. An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility.

Dr. Korinna Pilz, Global Head of Clinical R&D at InflaRx, noted: “Encouraged by our initial Phase II results, we are now rolling out the international Phase III part of the trial. Our team is driven by the prospect of adding to the global efforts in the fight against this pandemic and by advancing the development of a potential therapeutic for the sickest COVID-19 patients.”

The data from the Phase II part of the study, which evaluated IFX-1 treatment plus best supportive care and best supportive care alone in 30 patients, have been accepted for publication in the peer-reviewed journal, The Lancet Rheumatology.

Dr. Alexander Vlaar, the principal investigator of the study from Amsterdam University, Department of Intensive Care Medicine, commented: “We are very pleased that a distinguished, peer-reviewed journal has recognized the significance of the Phase II data for patients with severe COVID-19 induced pneumonia. The results demonstrate promising early efficacy signals, including lower mortality and organ dysfunction rates, and suggest that C5a inhibition might be beneficial in critically ill COVID-19 patients. However, these effects need to be confirmed in the large, well-powered Phase III part of the trial.”

IFX-1, which has recently been granted the International Nonproprietary Name (INN), vilobelimab, currently has additional ongoing Phase II studies in ANCA-associated vasculitis and Pyoderma Gangraenosum and has completed Phase IIb development in Hidradenitis Suppurativa, for which a Phase III clinical development strategy is currently being developed.

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