InflaRx Announces Decision to Enter Phase III Development of IFX-1 in Severe COVID-19 Induced Pneumonia

• 50% lower all-cause mortality rate and other efficacy trends were shown with IFX-1 in initial data from the randomized exploratory Phase II part of the Phase II/III trial
  
• Subject to regulatory approval, a randomized, double-blinded, placebo-controlled, multinational Phase III part of the trial will be initiated
• Primary endpoint of the planned Phase III part to be 28-day all-cause mortality       

JENA, Germany, July 21, 2020 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that the Company has decided to continue development with IFX-1 in severe COVID-19 induced pneumonia.  The Company plans to initiate a double-blinded, randomized, placebo-controlled Phase III trial that will be adequately powered for statistical analyses.

In the Phase III part of the study, subject to regulatory approval, the Company plans to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia. InflaRx plans to conduct the study at sites in the US, Europe, South America and potentially other regions. An interim analysis is currently planned after enrollment of 180 patients, with the potential for an early stop for efficacy or futility. In addition to the primary endpoint of 28-day all-cause mortality, other planned key endpoints include assessments of organ support and assessment of disease improvement on the ordinal scale. 

Dr. Korinna Pilz, Global Head of Clinical R&D at InflaRx, noted: “Data from the initial exploratory Phase II part of the study in patients with severe COVID-19 induced pneumonia suggested a positive impact of IFX-1 treatment on the all-cause mortality rate and other endpoints. Based on these encouraging results, we are excited to initiate the Phase III part of the trial, which we anticipate starting in the coming months.”

The Phase II part of the study evaluated IFX-1 treatment plus best supportive care compared to best supportive care alone for up to 28 days. The Phase II part was randomized and enrolled a total of 30 patients. The 28-day all-cause mortality rate was 13% (n = 2 out of 15) in the IFX-1 treatment arm compared to 27% (n = 4 out of 15) in the best supportive care arm. All deaths in the best supportive care arm occurred in COVID-19 induced multi-organ failure. In the IFX-1 treatment arm, one patient died after an acute ventilator tube complication (leakage) leading to hypoxia and one patient who met an exclusion criterion with a history of severe chronic obstructive pulmonary disease, which was not known at time point of enrollment, died of pulmonary failure. In the IFX‑1 treatment arm fewer patients experienced renal impairment assessed by estimated glomerular filtration rates and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations as a sign of reduction in tissue damage. A temporary, but statistically significant increase of D-dimer levels in the first days following IFX-1 administration was noted, as a potential signal for induction of blood clot lysis. No statistically significant group differences on the chosen primary endpoint of relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were detected.