InflaRx N.V., a biopharmaceutical company in the clinical stage of developing anti-inflammatory therapeutics that target the complement system, has announced that its first-of-its-kind monoclonal anti-human complement factor C5a antibody, Gohibic (vilobelimab), has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The EUA permits the use of Gohibic for treating COVID-19 in hospitalized adults who receive invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), provided it is initiated within 48 hours.
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, said:
“We are thrilled and very proud that the FDA has issued an EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug. Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. As a consequence, we continue to see mortality rates in the range of approximately 2,000 COVID-19-reported deaths per week in the U.S. as reported by the U.S. Centers for Disease Control and Prevention. Today’s announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible.”
The Emergency Use Authorization (EUA) for vilobelimab as a COVID-19 treatment was granted based on the Phase III PANAMO trial data. The trial was one of the largest randomized, double-blind placebo-controlled studies conducted on invasively mechanically ventilated COVID-19 patients in ICU. The trial enrolled 369 patients who received either six 800-mg infusions of vilobelimab or a placebo, in addition to standard care, including anti-coagulants, dexamethasone, and other immunomodulators.
The results of the trial, which have been published in The Lancet Respiratory Medicine, revealed a 23.9% reduction in 28-day all-cause mortality with vilobelimab treatment. InflaRx is presently in talks with the FDA to submit a BLA for complete approval of Gohibic in the COVID-19 indication, and it has also held productive meetings with the rapporteur and co-rapporteur teams of the European Committee for Medicinal Products for Human Use (CHMP) concerning a Marketing Authorization Application with the European Medicines Agency (EMA). Vilobelimab is also under development for other indications, such as pyoderma gangrenosum, with a Phase III trial now underway.
Prof. Renfeng Guo, M.D., Chief Scientific Officer and Founder of InflaRx, said:
“This EUA is a great recognition of our COVID-19-related research, which was based on over two decades of groundbreaking work on the tissue and organ-damaging effect of the complement factor C5a as part of the body’s immune response. InflaRx will evaluate broadening our development of vilobelimab in other areas of viral lung injury and viral sepsis where the mechanism has already been researched in pre-clinical models. Our COVID-19 results underscore the anti-inflammatory potential of inhibition of the terminal C5a and C5a receptor pathway in other inflammatory diseases.”
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 of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum and cutaneous squamous cell carcinoma.
The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.
InflaRx GmbH (in Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together “InflaRx”).
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a / C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.com.