InflaRx completes enrollment in phase III part of phase II/III vilobelimab study in severe Covid-19 patients

Jena, GermanyThursday, October 14, 2021, 18:00 Hrs  [IST]

InflaRx N.V., a clinical-stage biopharmaceutical company, announced 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, but statistically significant, increase in D-dimer levels in the first days following vilobelimab administration was noted, a potential signal for induction of blood clot lysis. No statistically significant group differences in the primary endpoint of relative change  from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were detected.

The data from the Phase II part of the study have been published in the peer-reviewed journal, The Lancet Rheumatology.

Vilobelimab 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, vilobelimab 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. Vilobelimab 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. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Over 300 people have been treated with vilobelimab in completed clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, ANCA-associated vasculitis and pyoderma gangraenosum, as well as other areas, including critical Covid-19 and cutaneous squamous cell carcinoma (cSCC).

InflaRx is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a.