JENA, Germany—InflaRx, a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, has announced interim results from the first 30 patients treated in the adaptive randomized Phase 2/3 trial in patients with severe COVID-19 pneumonia.
The Phase 2 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 five 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.
Also, 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.
“These are encouraging preliminary data which suggest that C5a inhibition might be beneficial in treating critically ill COVID-19 patients,” said Dr. Korinna Pilz, Global Head of Clinical R&D at InflaRx.
Added Prof. Niels Riedemann, CEO and co-founder of InflaRx: “InflaRx’s core expertise in the acute care field and our development work with IFX-1 in sepsis and viral lung injury put InflaRx in a scientifically strong position to develop IFX-1 in COVID-19. We are encouraged by these preliminary data.”
Serious adverse event (SAE) rates were comparable between groups, but the rate of pulmonary embolisms reported as SAEs was substantially lower in the IFX-1 treatment group. Upon review of the safety data, the independent data safety monitoring board recommended continuation of the trial into the Phase III part.
InflaRx is now evaluating continuing the study in an adequately powered, placebo-controlled, double blinded, Phase 3 part using 28-day all-cause mortality as the primary endpoint, an accepted regulatory primary endpoint for critical care studies.
IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development.