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InflaRx Completes Enrollment of Vilobelimab Phase III Study in Severe COVID-19
Study has enrolled 369 patients across 9 countriesTopline results expected to be available in Q1 2022 JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx
About this update from Inflarx N.v.
[{"type":"text","content":"Study has enrolled 369 patients across 9 countriesTopline results expected to be available in Q1 2022 JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients. The randomized, double-blind and placebo-controlled Phase III part of the Phase II/III study enrolled 369 mechanically ventilated patients with COVID-19 across sites in the EU, South America and other regions. Patients were randomized 1:1 to receive either vilobelimab or placebo; all patients received standard of care. The primary endpoint is 28-day all-cause mortality; key secondary endpoints include assessment of organ support and disease improvement. Treatment is still ongoing and topline results are expected to be available in Q1 2022. Dr. Korinna Pilz, Chief Clinical Development Officer, said: “There remains an urgent need for treatments for critically ill patients with severe COVID-19, and we are pleased that enrollment has completed in this trial. Based on our current expectations regarding when we will be able to lock the database and complete the data analyses, we expect to report topline results in Q1 2022. We are hopeful that vilobelimab can make a meaningful difference for COVID-19 patients. Should the data so warrant, we would then discuss with regulatory authorities the next steps.” The Phase II part of the study evaluated vilobelimab treatment plus best supportive care compared to best supportive care alone for up to 28 days. The Phase II part was randomized, open label and enrolled a total of 30 patients. The 28-day all-cause mortality rate was 13% (n = 2 of 15) in the vilobelimab treatment arm compared to 27% (n = 4 of 15) in the best supportive care arm. All deaths in the best supportive care arm occurred due to COVID-19-induced multi-organ failure. In the vilobelimab treatment arm, fewer patients experienced renal impairment assessed by estimated glomerular filtration rates compared to best supportive care alone, and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations, a sign of reduction in tissue damage. A temporary,...