InflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19
- IFX-1 treatment showed a trend in lower 28-day all-cause mortality rate, along with trends of maintained kidney function, faster normalization in lymphocyte counts and greater reduction in LDH in patients with severe COVID-19 pneumonia
- InflaRx is now evaluating the continuation into a placebo-controlled Phase III part of the trial with 28-day all-cause mortality as the primary endpoint
JENA, Germany, June 17, 2020 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today interim results from the first 30 patients treated in the adaptive randomized Phase II/III trial in patients with severe COVID-19 pneumonia.
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. Relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) was assessed as the primary endpoint along with additional clinical parameters until day 28. Relative change in the oxygenation index at day 5 showed no differences between treatment groups. However, IFX-1 treatment was associated with a lower 28-day all-cause mortality when compared to the best supportive care group, along with trends in disease improvement, as evidenced by fewer patients experiencing renal impairment assessed by estimated glomerular filtration rates, more patients showing reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations. In IFX-1-treated patients, pulmonary embolisms reported as serious adverse events were lower compared to the best supportive care arm. Also, a temporary increase of D-dimer levels, as potential expression of induction of blood clot lysis, was detected in the first days after initiation of IFX-1 treatment. The data are being prepared for submission to a scientific journal1.
Dr. Korinna Pilz, Global Head of Clinical R&D at InflaRx, commented: “These are encouraging preliminary data which suggest that C5a inhibition might be beneficial in treating critically ill COVID-19 patients.”
A total of 30 patients were randomized in the trial, and 15 patients were treated in each arm: IFX-1 plus best supportive care or best supportive care alone. Over a treatment period of 28 days, patients in the IFX-1 arm received a maximum of seven doses of 800 mg IFX-1 intravenously on separate days. At randomization, 18 patients were intubated (60%), and 12 patients (40%) had other oxygen supply. A higher number of patients with 2 or more comorbidities associated with increased COVID-19 mortality were reported in the IFX-1 treatment group compared to best supportive care group. Twenty-eight-day all-cause mortality in the IFX-1 treatment group was 13% (2 out of 15) versus 27% (4 out of 15) in the control group. In the best supportive care group, four patients died of COVID-19-induced multi-organ failure, and three of them had pulmonary embolisms reported as a serious adverse event. In the IFX-1 arm, one patient died after an acute ventilator tube complication (leakage) and one patient with a history of severe chronic obstructive pulmonary disease died of pulmonary failure.