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 hospitalised adults.
The monoclonal anti-human complement factor C5a antibody should be initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
Professor Niels C Riedemann, CEO and Founder of InflaRx, said: “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 US.”
The data supporting the EUA were based on the previously announced results of the multicentre Phase III PANAMO trial. The trial is one of the largest 1:1 randomised, double-blind placebo-controlled trials in invasively mechanically ventilated Covid-19 patients in intensive care units.
A total of 369 patients were randomly assigned to the vilobelimab treatment group (six 800mg infusions) or the placebo group. Both groups also received standard of care, which included treatment with anti-coagulants, dexamethasone and other immunomodulators.
The data showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.
Professor Renfeng Guo, Chief Scientific Officer and Founder of InflaRx, added: “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.”