InflaRx was granted emergency use authorization for the treatment of COVID-19
InflaRx NV, a German company developing anti-inflammatory therapy targeting the complement system, has announced that Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in adults who hospitalized.
Vilobelimab is a class one monoclonal anti-human complement factor C5a antibody that acts on the immune system and not on viruses.
Niels C. Riedemann, CEO and founder of InflaRx, said: “We are very pleased and very proud that the FDA has issued an EUA for vilobelimab to treat this group of very sick patients, recognizing the lifesaving potential of this class-one drug. Despite the availability of vaccines and other treatments for the early stages of COVID-19 disease, many patients still develop viral sepsis and progress to critical status, often requiring invasive mechanical ventilation.
“As a result, we continue to see death rates in the range of approximately 2,000 reported COVID-19 deaths per week in the US as reported by the US 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 quickly as possible.”
The data supporting the EUA are based on results of the previously announced multicenter PANAMO phase III trial, which showed Gohibic treatment reduced mortality by 23.9% compared to placebo.
InflaRx filed for authorization last July.
InflaRx developed Gohibic for other conditions
InflaRx said it was continuing discussions with the FDA regarding Gohibic’s full approval in this indication for COVID-19. InflaRx said it had also completed an encouraging meeting with the reporting team and co-reporters from the European Committee on Medicinal Products for Human Use (CHMP) regarding the planned Marketing Authorization Application with the European Medicines Agency (EMA).
In addition, InflaRx continues to develop vilobelimab for other indications, including pyoderma gangrenosum, for which the company is currently initiating phase III trials.
Renfeng Guo, chief scientific officer and founder of InflaRx, said: “This EUA is great recognition of our COVID-19 related research, which is based on more than two decades of groundbreaking work on the tissue and organ damage effects of complement. factor C5a as part of the body’s immune response. InflaRx will evaluate the expansion of our development of vilobelimab in other areas of viral lung injury and viral sepsis where the mechanisms have been studied in pre-clinical models. Our COVID-19 results underscore the anti-inflammatory potential of inhibition of terminal C5a and C5a receptor pathways in other inflammatory diseases.”
Gohibic has not been approved, but has been cleared for emergency use by the FDA under the EUA, for the treatment of COVID-19 in adults who are hospitalized when started within 48 hours of receiving IMV, or ECMO.
Emergency use of GOHIBIC is only permitted for the duration of the declaration that there are circumstances justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.
About vilobelimab
Vilobelimab is the first in its class monoclonal anti-human complement factor C5a antibody, which blocks the biological activity of C5a and exhibits high selectivity to 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 C5-blocking molecules.
In pre-clinical studies, vilobelimab has been shown to control inflammatory response-driven tissue and organ damage by specifically blocking C5a as the primary “booster” of this response. In addition to the development of COVID-19, vilobelimab is also being developed for various indications of debilitating or life-threatening inflammation, including pyoderma gangrenosum and squamous cell carcinoma of the skin.
